Open Label Extension Study of PREOS (OLES)

May 13, 2021 updated by: Shire

An 18-Month Open Label Extension Study (OLES) of the Safety and Efficacy of Recombinant Human Parathyroid Hormone, rhPTH(1-84), ALX1-11, in Women With Postmenopausal Osteoporosis Who Participated in Protocol ALX1-11-93001 (TOP Study)

This is an Open Label Extension Study (OLES) for patients who participated in the 18 month double-blind, placebo-controlled, Phase III trial (Protocol ALX1 11 93001 the TOP Study) studying the effect of ALX1-11, recombinant human parathyroid hormone, rhPTH(1-84), on vertebral fracture incidence. The primary objective of this study is to evaluate the safety of continued dosing with ALX1-11, up to a maximum of 24 months, in postmenopausal osteoporotic women who participated in Protocol ALX1 11 93001.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Effects of ALX1-11 on bone mineral density (BMD) have been documented in a dose-finding Phase II clinical trial in osteoporotic postmenopausal women, supplemented with calcium and Vitamin D3 but without any other treatment for osteoporosis. The anabolic effects of ALX1-11 in the lumbar vertebrae were statistically significant after the 12-month treatment period and more pronounced than any approved therapy. Additionally, animal studies have shown that the new bone formed by treatment with ALX1 11 is of good quality both histologically and biomechanically.

The primary objective of this OLES is to evaluate the safety of continued dosing with ALX1-11, up to a maximum of 24 months, in postmenopausal osteoporotic women who participated in Protocol ALX1-11-93001. A secondary objective is to assess the change in vertebral BMD and compare the changes observed in patients who received ALX1-11 or placebo in Protocol ALX1-11-93001.

Patients will receive 100 µg/day of ALX1-11 daily via subcutaneous injection in this study. Patients should continue the study drug dosing frequency they were following at the end of Protocol ALX1-11-93001.

To enhance their safety, all patients will continue to take their daily supplements of 700 mg calcium and 400 IU Vitamin D3 prior to and during this OLES. Patients whose calcium supplement was discontinued during Protocol ALX1-11-93001 should maintain that discontinuation during this OLES. However upon completion of ALX1-11 dosing in the OLES, oral calcium supplement at a dose of 700 mg each morning should be restarted and maintained for the remainder of the OLES. Additional supplemental calcium and/or Vitamin D3 will not be permitted. A daily multivitamin supplement may be taken during the study. However, the multivitamin must contain no more than 200 mg/day calcium and 400 IU/day Vitamin D3. Patients will be monitored for the development of hypercalcemia and/or hypercalciuria and managed as described in Appendices 4 and 5.

There will be a stopping rule in this OLES. Any patient who reaches a BMD T score of -0.5 or above, at the site or sites (vertebral, total hip, or femoral neck) that were used in the qualification of the patient for Protocol ALX1 11-93001, will stop ALX1-11 treatment. The patient must continue on calcium and Vitamin D3 and be followed for the remainder of this 18-month OLES. At the time of discontinuation, the patient must complete the Month 18 evaluations (Appendix 1A or 1B).

The Clinical Advisory Board (CAB) used in Protocol ALX1-11-93001 will be involved in reviewing any patient issues that arise in this OLES. This group will provide not only continuity of care for all the patients, but also enhanced and consistent safety monitoring for patients participating in the OLES.

Study Type

Interventional

Enrollment (Actual)

1683

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • BUE
      • Buenos Aires, BUE, Argentina, C1012AAR
        • 'IDIM
      • Buenos Aires, BUE, Argentina, C1117ABH
        • 'Centro Médico T.I.E.M.P.O
      • Buenos Aires, BUE, Argentina, C1221ADC
        • 'Hospital Ramos Mejía
    • CBA
      • Capital Federal, CBA, Argentina, C1114AAI
        • 'Centro de Osteopatias Medicas
  • Brazil
    • PR
      • Curitiba, PR, Brazil, 80060
        • 'Universidade Federal do Paraná
    • RJ
      • 'Rio de Janeiro, RJ, Brazil, 20020
        • 'Hospital Santa Casa de Misericórdia do Rio de Janeiro
      • Rio de Janeiro, RJ, Brazil, 20221
        • 'Hospital do Servidor Público do Rio de Janeiro
    • SP
      • Sao Paulo, SP, Brazil, 04038
        • 'Universidade Federal de São Paulo
      • Sao Paulo, SP, Brazil, 04062
        • 'Instituto de Saúde e Bem Estar da Mulher
      • Sao Paulo, SP, Brazil, 04231
        • 'Hospital Heliópolis
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, 'T2N 4N1
        • 'Heritage Medical Research Clinic
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 2N6
        • Osteoporosis Research Center
    • Manitoba
      • Winnipeg, Manitoba, Canada, 'R3A 1M3
        • 'Manitoba Clinic
    • Ontario
      • Hamilton, Ontario, Canada, L8N 1Y2
        • Charlton medical Centre
      • Kitchener, Ontario, Canada, N2M 5N6
        • Rafat Faraawi
      • London, Ontario, Canada, N6A 4V2
        • St. Joseph's Health Centre
      • London, Ontario, Canada, 'N6G 2M3
        • 'Centre for Activity and Aging
      • Montreal, Ontario, Canada, 'H3A 1A1
        • 'Royal Victoria Hospital
      • Oakville, Ontario, Canada, L6J 1X8
        • Oakville Bone Center
      • Ottawa, Ontario, Canada, 'K1H 8L6
        • Ottawa Hospital
      • Toronto, Ontario, Canada, 'M4N 3M5
        • 'Sunnybrook and Women's College Health Science Center
      • Toronto, Ontario, Canada, 'M5C 2T2
        • 'St. Michael's Hospital
      • Toronto, Ontario, Canada, 'M5S 1B2
        • 'Osteoporosis Research Program
      • Windsor, Ontario, Canada, N8W 5L7
        • Jude F. Rodrigues
    • Prince Edward Island
      • Charlottetown, Prince Edward Island, Canada, C1A 6A4
        • 'Riverside Medical Centre
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • 'Complexe Hospitalier de la Sagami
      • Montreal, Quebec, Canada, 'H1T 2M4
        • 'Hopital Maisonneuve-Rosemont
      • Montreal, Quebec, Canada, 'H2X 1P1
        • 'Centre de Recherche du CHUM - Hopital Saint-Luc
      • Sainte-Foy, Quebec, Canada, G1V 3M7
        • Centre de recherche - CORQ
      • Sherbrooke, Quebec, Canada, J1J 2B8
        • Novabyss Research Clinic
    • Saskatchewan
      • 'Saskatoon, Saskatchewan, Canada, 'S7K 0H6
        • 'Saskatoon Osteoporosis Centre
  • Israel
      • Beer Sheva, Israel, 84101
        • 'Soroka Medical Center
      • Haifa, Israel, 31096
        • 'Rambam Medical Center
      • Haifa, Israel, 34162
        • 'Lin Medical Center
      • Jerusalem, Israel, 91240
        • 'Hadassah University Hospital
      • Ramat Gan, Israel, 52621
        • 'Chaim Sheba Medical Center
      • Tel Aviv, Israel
        • 'Lis Maternity Hospital
  • Mexico
      • Monterrey Nuevo Leon, Mexico, 64040
        • 'Hospital Universitario de Monterrey
    • DF
      • Mexico, DF, Mexico, 06700
        • 'Instituto Mexicano de Investigacion Clinica
      • Mexico, DF, Mexico, 11800
        • 'Hospital de Mexico
    • Emex
      • 'Huixquilucan, Emex, Mexico, 52763
        • 'Hospital Angeles de las Lomas
    • GTO
      • Leon, GTO, Mexico, 37000
        • 'Hospital Aranda de la Parra
    • JAL
      • Guadalajara, JAL, Mexico, 44340
        • 'OPD Hospital Civil de Guadalajara Dr. Juan I. Menchaca
      • Guadalajara, JAL, Mexico, 44650
        • 'Hospital Civil de Belem
      • Guadalajara, JAL, Mexico, 44670
        • 'Medica Monraz
  • Romania
      • Cluj-Napoca, Romania, 3400
        • 'Spitalul Clinic Judetean Cluj-Napoca
  • Russian Federation
      • Moscow, Russian Federation, 117036
        • 'Scientific Center of Endocrinology of RAMS
      • Moscow, Russian Federation, 125315
        • 'Russian Academy for Advanced Medical Studies
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • 'The University of Alabama at Birmingham
      • Huntsville, Alabama, United States, 35801
        • 'Rheumatology Associates of North Alabama
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • 'Radiant Research - Phoenix North
    • California
      • Beverly Hills, California, United States, 90211
        • 'Osteoporosis Medical Center
      • Concord, California, United States, 94520
        • 'East Bay Clinical Trial Center
      • Loma Linda, California, United States, 92354
        • 'Loma Linda Osteoporosis Research Center
      • Oakland, California, United States, 94612
        • Foundation for Osteoporosis Research
      • Palm Desert, California, United States, 92260
        • 'Desert Medical Advances
      • Palo Alto, California, United States, 94304
        • 'VA Palo Alto Health Care System
      • Rancho Cucamonga, California, United States, 91730
        • 'Boling Clinical Trials
      • San Diego, California, United States, 92120
        • 'S.D. Arthritis & Osteoporosis Medical Clinic
      • San Diego, California, United States, 92123
        • 'Radiant Research - San Diego
      • San Francisco, California, United States, 94110
        • 'San Francisco General Hospital
    • Colorado
      • Longmont, Colorado, United States, 80501
        • 'Longmont Medical Research Network
    • Connecticut
      • Hamden, Connecticut, United States, 06518
        • 'Northeast Clinical Research, LLC
    • Florida
      • Boca Raton, Florida, United States, 33486
        • 'RASF - Clinical Research Center
      • Hollywood, Florida, United States, 33021
        • 'The Center for Diabetes and Endocrine Care
      • Inverness, Florida, United States, 34452
        • 'Florida Wellcare Alliance
      • Ocala, Florida, United States, 34471
        • 'Renstar Medical Group
      • Palm Harbor, Florida, United States, 34684
        • 'The Arthritis Center
      • South Miami, Florida, United States, 33143
        • 'The Centre for Arthritis and Rheumatic Diseases
      • Stuart, Florida, United States, 34996
        • 'Radiant Research - Stuart & LakeWorth
      • West Palm Beach, Florida, United States, 33409
        • 'Palm Beach Research Center
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • 'Radiant Research
    • Idaho
      • Boise, Idaho, United States, 83702
        • 'Intermountain Orthopaedics
    • Illinois
      • Chicago, Illinois, United States, 60637
        • 'The University of Chicago
      • Chicago, Illinois, United States, 60612
        • Rush-Prebyterian-St.Luke's Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • 'University Hospital & Outpatient Center
    • Iowa
      • Des Moines, Iowa, United States, 50322
        • 'Mercy Arthritis and Osteoporosis Center
    • Kansas
      • Wichita, Kansas, United States, 67208
        • 'Wichita Clinic
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • 'Ochsner Clinic
    • Maine
      • Bangor, Maine, United States, 04401
        • 'Maine Center for Osteoporosis Research & Education
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • 'Bethesda Health Research Center
      • Cumberland, Maryland, United States, 21502
        • 'The Osteoporosis and Clinical Trials Center
      • Frederick, Maryland, United States, 21702
        • 'Arthritis & Osteoporosis Center of Maryland
      • Wheaton, Maryland, United States, 20902
        • 'The Center for Rheumatology and Bone Research
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • 'Brigham & Women's Hospital
    • Michigan
      • Detroit, Michigan, United States, 48236
        • 'Michigan Bone & Mineral Clinic
    • Mississippi
      • Olive Branch, Mississippi, United States, 38654
        • 'Desoto Family Medical Center
    • Missouri
      • Springfield, Missouri, United States, 65807
        • 'St. John's Medical Research Group
    • New Hampshire
      • Concord, New Hampshire, United States, 03301
        • 'Arthritis, Osteoporosis Muscle Skeletal Disease Center
    • New Jersey
      • South Plainfield, New Jersey, United States, 07080
        • 'Anderson and Collins Clinical Research Inc.
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • 'New Mexico Clinical Research and Osteoporosis Center
      • Albuquerque, New Mexico, United States, 87108
        • 'Lovelace Scientific Resources
    • New York
      • New York, New York, United States, 10032
        • 'College of Physicians and Surgeons, Columbia University
      • Rochester, New York, United States, 14609
        • 'Rochester Clinical Research Inc.
      • Stony Brook, New York, United States, 11794
        • 'Stony Brook Clinical Research Trials Center
      • White Plains, New York, United States, 10605
        • 'Physicians Clinical Research Services
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • 'Duke University Medical Center
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • 'Odyssey Research Services
      • Fargo, North Dakota, United States, 58103
        • Michael J. Lillestol
      • Grand Forks, North Dakota, United States, 58201
        • 'Altru Health Systems / Altru Research Center
      • Minot, North Dakota, United States, 58701
        • 'Odyssey Research Services
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • 'Cleveland Clinic Foundation
      • Mayfield, Ohio, United States, 44143
        • 'David R. Mandel M.D. Inc.
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74114
        • 'Oklahoma Center for Arthritis Therapy & Research, Inc.
    • Oregon
      • Medford, Oregon, United States, 97504
        • 'Osteoporosis Center
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • 'Altoona Center for Clinical Research
      • Philadelphia, Pennsylvania, United States, 19131
        • 'Thomas Jefferson University
      • Pittsburgh, Pennsylvania, United States, 15213
        • 'University of Pittsburgh Medical Center
      • West Reading, Pennsylvania, United States, 19611
        • 'Clinical Research Center of Reading LLP
      • Wyomissing, Pennsylvania, United States, 19610
        • 'Radiant Research
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • 'Rhode Island Hospital
      • Providence, Rhode Island, United States, 02908
        • 'Roger Williams Medical Center
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • 'Radiant Research
      • Columbia, South Carolina, United States, 29204
        • 'Columbia Arthritis Center, PA
      • Greer, South Carolina, United States, 29651
        • 'Radiant Research
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • 'Rapid City Medical Center
      • Sioux Falls, South Dakota, United States, 57105
        • 'Averna Research Institute
      • Watertown, South Dakota, United States, 57201
        • 'Brown Clinic
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • 'Clinsearch
    • Texas
      • Dallas, Texas, United States, 75235
        • 'Radiant Research/Dallas
      • Houston, Texas, United States, 77024
        • 'Breco Research Inc.
      • Midland, Texas, United States, 79705
        • 'Diabetes Center of the Southwest
      • San Antonio, Texas, United States, 78229
        • 'Diabetes & Glandular Disease Research Associates, P.A.
      • San Antonio, Texas, United States, 78229
        • 'Radiant Research San Antonio
    • Utah
      • Sandy, Utah, United States, 84070
        • 'Salt Lake Women's Center
    • Vermont
      • Burlington, Vermont, United States, 05401
        • 'Fletcher Allan Health Center, UHC Campus 1
    • Virginia
      • Newport News, Virginia, United States, 23606
        • 'Center for Arthritis and Diabetes
      • Richmond, Virginia, United States, 23294
        • 'National Clinical Research, Inc.
      • Richmond, Virginia, United States, 23298
        • 'MCV Physicians Program for Osteoporosis
    • Washington
      • Seattle, Washington, United States, 98105
        • 'Osteoporosis Research Group
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • 'University of Wisconsin Medical Foundation
      • Milwaukee, Wisconsin, United States, 53226
        • 'Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women who completed 18 months of treatment in Protocol ALX1-11-93001; or

  • Women prematurely discontinued from Protocol ALX1-11-93001 who want to participate in OLES for the events listed below must have their clinical course reviewed and approved by the CAB for enrollment into the OLES:

    • Clinical or incident lumbar vertebral fractures as assessed by the central imaging organization
    • Clinical or incident hip fracture
    • Confirmed bone loss at A/P lumbar vertebra or total hip or femoral neck as assessed by the central imaging organization
  • Body weight below 40 kg
  • Development of an exclusion criterion in Protocol ALX1-11-93001
  • It must be accepted by patients whose clinical courses are reviewed by the CAB that participation in OLES may require additional tests at baseline and/or during the study to ensure their utmost safety.
  • Women with the ability to self-administer a daily injection or have a designee who will give the injections;
  • Women who are capable of understanding and giving written, voluntary informed consent before the start of open-label dosing with ALX1-11.

Exclusion Criteria:

A. History or Concurrent Illness:

Disorders of Immunity Endocrine system Gastrointestinal system Kidney and collecting system Liver, biliary tract and pancreatic systems Musculoskeletal system

  • Patients with chronic, active joint disease requiring more than one intra-articular injection every 6 months Neoplasia

  • Patients who have had squamous or basal cell carcinoma of the skin may enter this study if:

    1. The lesion(s) were fully resected with clear margins described in a written report by a pathologist, and

    2. The patient has had no recurrence of lesions for at least one year from the time of the original resection.

      Nervous system Vascular, respiratory and cardiac system *Significant diseases or disorders are determined by history, physical exam or laboratory tests and judged by the Principal Investigator to be significant.

      B. Concurrent Medication:

      Patients may not use any of the following therapies while they are enrolled in this OLES without permission from the Sponsor and the PMO:

      • Tetracycline antibiotics for four weeks prior to bone biopsy
      • Any PTH analogs [e.g., rhPTH(1-84), PTH(1-34), PTHrP and analogs]
      • Fluoride
      • Strontium
      • Phenytoin for seizure control
      • Any investigational drug other than ALX1-11
      • Anabolic steroids or androgens
      • Active Vitamin D3 metabolites and analogs, e.g., calcitriol
      • Systemic corticosteroids, more than 5 mg/day prednisone or a systemic corticosteroid formulation equivalent to 5 mg/day prednisone

    1. A patient who has been enrolled into the OLES and needs to receive an acute bolus of steroids (oral or injectable) for a self-limited illness may continue treatment in the study if the following requirements are met:

    1. Exposure to steroids will be limited to no more than 30 consecutive days
    2. The maximal dose of steroid (prednisone equivalent) must be limited to no more than 225 mg (7.5 mg each day for 30 days)

    3. The illness is acute in nature and is not expected to recur during the remaining period of the study

      • Bisphosphonates, including investigational bisphosphonates
      • Calcitonin
      • Estrogen replacement therapy by oral, transdermal or intramuscular administration
      • SERM drugs, e.g., tamoxifen, raloxifene, Evista

      • Vaginal application of estrogen-containing creams unless the dose is:

        1. conjugated estrogen or estradiol: maximum of 0.5 g twice each week (total of 1.0 g weekly)
        2. Estrace (Ogen): maximum of 1.0 g twice each week (total of 2.0 g weekly)
      • Daily inhaled corticosteroid unless dose is equivalent to <1200 µg/day of beclomethasone
      • Cytostatics, e.g., azathioprine, recombinant human tumor necrosis fusion (Fc) protein, monoclonal antibody against tumor necrosis factor (e.g., remicade [infliximab]

      • Methotrexate

        1. The antimetabolite, methotrexate, which interferes with DNA synthesis, repair and cellular replication should not be used by patients participating in this OLES.
      • In general, immunomodulatory agents with antiproliferative activity are not permitted as a concomitant medication in this OLES.

      • Intra-articular injections

        1. Patients may receive a maximum of one intra-articular injection (ONE JOINT ONLY) every 6 months while participating in this OLES. The joint that is injected may be a different joint every 6 months. The dose of corticosteroid injected should not exceed the anti-inflammatory equivalent dose of Prednisone 40 mg suspension. The dose and volume should be adjusted downward as appropriate to the size of the joint.

      • Provera is an acceptable concomitant medication when used according to the label instructions

      Patients may be enrolled in this OLES if they have been stabilized on the following therapy for the specified amount of time:

      • Thyroid Hormone (<0.1 mg/day thyroxine) therapy for at least 6 months If taking > 0.1 mg/day but < 0.2 mg/day, must have serum TSH level 1. > 0.1mU/L. Patients will be excluded if they are taking doses of > 0.2 mg/day.

        2. However, if a patient has had a minimal change in L-thyroxine dose of < 0.025 mg/day within 6 months of the baseline visit, and has been on this new dose for at least 2 months, the patient may be enrolled in this study. The patient's history with L-thyroxine must be clearly documented in the source documents.

        3. If a patient requires an increase in their thyroid replacement dose, as recommended by a physician who is caring for the patient, after enrollment in this OLES, the patient must have a TSH and T4 level within 3 months of the dose change to ensure the patient does not become hyperthyroid

      • Stable dosage of thiazide for at least 3 consecutive months

      C. Laboratory Values and Physical Examination Findings:

      - Serum calcium greater than 10.7 mg/dL (2.66 mmol/L) at baseline will be managed as outlined in Appendix 4

      - Urinary calcium to creatinine ratio greater than or equal to 1 at baseline will be managed as outlined in Appendix 5

      • Elevated total serum alkaline phosphates (> 400 U/L) at baseline will be managed as outlined in Appendix 6 except as noted for Latin and South American countries.
      • Any other clinically significant abnormal value as judged by the investigator

      D. Substance Abuse:

      Alcohol and/or drug abuse

      E. Compliance:

      Suspected or confirmed poor compliance in completing clinical trial evaluations and/or clinical trial required questionnaires

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
All patients entering the study will receive 100mcg daily for up to 6 months, making their total exposure 24 months
Drug: ALX1-11 (drug)
100 mcg PTH(1-84) injected subcutaneously daily in either the thrigh and abdomen.
Other Names:
  • PREOS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the safety of continued dosing with ALX1-11, up to a maximum of 24 months, in postmenopausal osteoporotic women who participated in Protocol ALX1-11-93001 (TOP).
Time Frame: 24 months of treatment
24 months of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the continued efficacy of once-daily treatment with ALX1-11 for maintaining increases in BMD and other measures of bone quality and strength.
Time Frame: 24 months of treatment
24 months of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shire

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2001

Primary Completion (Actual)

April 13, 2005

Study Completion (Actual)

April 13, 2005

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Actual)

May 17, 2021

Last Update Submitted That Met QC Criteria

May 13, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL1-11-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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