A Study of Monthly Risedronate for Osteoporosis

April 15, 2013 updated by: Warner Chilcott

A Phase III, Multicenter, Double-blind, Randomized, Active-controlled, Parallel Group, Non-inferiority Study Comparing 150 mg Risedronate Monthly With 5 mg Risedronate Daily in the Treatment of Postmenopausal Osteoporosis (PMO)

The purpose of this trial is to study the efficacy of a single-dose monthly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The comparator arms of this risedronate study are 150 mg monthly and 5 mg daily.

Study Type

Interventional

Enrollment (Actual)

1294

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
      • Buenos Aires, Argentina
        • Research Site
      • Capital Federal, Argentina
        • Research Site
  • Australia
      • Geelong, Australia
        • Research Site
      • Heidelberg, Victoria, Australia
        • Research Site
      • Saint Leonards, Australia
        • Research Site
  • Belgium
      • Brussels, Belgium
        • Research Site
      • Gent, Belgium
        • Research Site
      • Leuven, Belgium
        • Research Site
      • Liege, Belgium
        • Research Site
      • Mont Godinne, Belgium
        • Research Site
  • Brazil
      • Rio de Janeiro, Brazil
        • Research Site
      • Sao Paulo, Brazil
        • Research Site
  • Canada
      • Calgary, Canada
        • Research Site
      • Montreal, Canada
        • Research Site
      • Sainte Foy, Canada
        • Research Site
      • Saskatoon, Canada
        • Research Site
  • Estonia
      • Parnu, Estonia
        • Research Site
      • Tartu, Estonia
        • Research Site
  • Finland
      • Helsinki, Finland
        • Research Site
      • Kuopio, Finland
        • Research Site
      • Oulu, Finland
        • Research Site
      • Turku, Finland
        • Research Site
  • France
      • Amiens Cedex 1, France
        • Research Site
      • Lyon Cedex, France
        • Research Site
      • Orleans, France
        • Research Site
      • Paris, France
        • Research Site
      • Toulouse, France
        • Research Site
      • Vandoeuvre Les Nancy, France
        • Research Site
  • Hungary
      • Balatonfured, Hungary
        • Research Site
      • Budapest, Hungary
        • Research Site
      • Gyor, Hungary
        • Research Site
      • Miskolc, Hungary
        • Research Site
      • Nagykanizs, Hungary
        • Research Site
  • Lebanon
      • Beirut, Lebanon
        • Research Site
  • Norway
      • Oslo, Norway
        • Research Site
      • Paradis, Norway
        • Research Site
      • Trondheim, Norway
        • Research Site
  • Poland
      • Bialystok, Poland
        • Research Site
      • Warszawa, Poland
        • Research Site
  • Spain
      • Barcelona, Spain
        • Research Site
      • Granada, Spain
        • Research Site
      • Madrid, Spain
        • Research Site
  • United States
    • Colorado
      • Lakewood, Colorado, United States, 80227
        • Research Site
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • Research Site
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Research Site
    • Nebraska
      • Omaha, Nebraska, United States, 068131
        • Research Site
    • New York
      • West Haverstraw, New York, United States, 10983
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Research Site
    • Oregon
      • Portland, Oregon, United States, 97212
        • Research Site

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

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female: 50 years of age or older
  • >5 years since last menses natural or surgical
  • have lumbar spine BMD (bone mineral density) more that 2.5 standard deviations (SD) below the young adult mean, or have 1-spine BMD more than 2.0 SD below the young adult female mean value and also have at least one prevalent vertebral body fracture

Exclusion Criteria:

  • history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia
  • BMI (body mass index) >32 kg/m^2
  • use of medications within 3 months of starting study drug that impact bone metabolism such as glucocorticoids, estrogens, calcitonin, calcitriol, other bisphosphonates and parathyroid hormone
  • hypocalcemia or hypercalcemia of any cause
  • markedly abnormal clinical laboratory measurements that are assessed as clinically significant by the investigator

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
5 mg risedronate, once daily for 2 years
Drug: risedronate
tablet, 5 mg risedronate, once a day for 2 years
Drug: risedronate
oral, 150 mg risedronate, once a month for 2 years
EXPERIMENTAL: 2
150 mg risedronate taken once a month for 2 years
Drug: risedronate
tablet, 5 mg risedronate, once a day for 2 years
Drug: risedronate
oral, 150 mg risedronate, once a month for 2 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12-Endpoint in Women With Postmenopausal Osteoporosis, Primary Efficacy Population
Time Frame: Baseline to Month 12 - Endpoint
BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. LOCF - last observation carried forward (Last post-baseline measurement available to Month 12).
Baseline to Month 12 - Endpoint

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population
Time Frame: Baseline to Month 12
BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.
Baseline to Month 12
Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population
Time Frame: Baseline to Month 12
BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.
Baseline to Month 12
Percent Change From Baseline in Lumbar Spine BMD at Month 24-Endpoint, Endpoint Population (Month 24)
Time Frame: Baseline to Month 24 - Endpoint
BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. LOCF - last observation carried forward (Last post-baseline measurement available to Month 24).
Baseline to Month 24 - Endpoint
Percent Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population
Time Frame: Baseline to Month 24
BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.
Baseline to Month 24
Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population
Time Frame: Baseline to Month 24
BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.
Baseline to Month 24
Change From Baseline in Urine Type-1 Collagen Cross-linked-N-telopeptide Corrected for Creatinine Clearance (NTX/Cr) at Month 6, ITT Population
Time Frame: Baseline to Month 6
Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 & 24. nmol BCE / mmol Creatinine = nanomoles bone collagen equivalents / millimoles Creatinine
Baseline to Month 6
Percent Change From Baseline in Urine NTX/Cr at Month 6, ITT Population
Time Frame: Baseline to Month 6
Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 & 24.
Baseline to Month 6
Change From Baseline in Urine NTX/Cr at Month 24, ITT Population
Time Frame: Baseline to Month 24
Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 & 24.
Baseline to Month 24
Percent Change From Baseline in Urine NTX/Cr at Month 24, ITT Population
Time Frame: Baseline to Month 24
Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 & 24.
Baseline to Month 24
Change From Baseline in Serum Type-1 Collagen Cross-linked C-telopeptide (CTX) at Month 6, ITT Population
Time Frame: Baseline to Month 6
ng / mL = nanograms / milliliter. Assayed by electrochemiluminescent immunoassay.
Baseline to Month 6
Percent Change From Baseline in Serum CTX at Month 6, ITT Population
Time Frame: Baseline to Month 6
Assayed by electrochemiluminescent immunoassay.
Baseline to Month 6
Change From Baseline in Serum CTX at Month 24, ITT Population
Time Frame: Baseline to Month 24
Assayed by electrochemiluminescent immunoassay.
Baseline to Month 24
Percent Change From Baseline in Serum CTX at Month 24, ITT Population
Time Frame: Baseline to Month 24
Assayed by electrochemiluminescent immunoassay.
Baseline to Month 24
Change From Baseline in Serum Bone-specific Alkaline Phosphatase (BAP) at Month 6, ITT Population
Time Frame: Baseline to Month 6
ug / L = micrograms per liter, Assayed by ELISA (enzyme-linked immunosorbent assay)
Baseline to Month 6
Percent Change From Baseline in Serum BAP at Month 6, ITT Population
Time Frame: Baseline to Month 6
Assayed by ELISA (enzyme-linked immunosorbent assay)
Baseline to Month 6
Change From Baseline in Serum BAP at Month 24, ITT Population
Time Frame: Baseline to Month 24
Assayed by ELISA (enzyme-linked immunosorbent assay)
Baseline to Month 24
Percent Change From Baseline in Serum BAP at Month 24, ITT Population
Time Frame: Baseline to Month 24
Assayed by ELISA (enzyme-linked immunosorbent assay)
Baseline to Month 24
Number of Participants With New Vertebral Fracture at Month 12, ITT Population
Time Frame: Baseline to Month 12
At least 1 new fractured vertebra
Baseline to Month 12
Number of Participants With New Vertebral Fracture at Month 24, ITT Population
Time Frame: Baseline to Month 24
At least 1 new fractured vertebra
Baseline to Month 24

Collaborators and Investigators

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

Sponsor

Warner Chilcott

Collaborators

Sanofi

Investigators

  • Study Director: Sal Bartelmo, MD, P&G

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

October 1, 2005

Primary Completion (ACTUAL)

March 1, 2008

Study Completion (ACTUAL)

April 1, 2008

Study Registration Dates

First Submitted

October 28, 2005

First Submitted That Met QC Criteria

October 28, 2005

First Posted (ESTIMATE)

November 1, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

April 22, 2013

Last Update Submitted That Met QC Criteria

April 15, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005032
  • EFC6062 AND HMRF004M/3001

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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