PaTH Study: Parathyroid Hormone and Alendronate for Osteoporosis

February 4, 2013 updated by: Dennis Black

Clinical Trial of Parathyroid Hormone (PTH) and Alendronate in Combination in the Treatment of Osteoporosis

This 2-year study will test the effectiveness of combining parathyroid hormone (PTH) and alendronate for treating osteoporosis in postmenopausal women. Alendronate is a drug used to treat osteoporosis and primarily prevents bone loss, whereas PTH increases bone formation. We will treat the study participants either with PTH and alendronate, alendronate alone, or PTH alone. We will determine the effects of these treatments by looking for changes in bone mineral density in the hip and spine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The PaTH study is a 2-year, multicenter, double-blind, placebo-controlled trial to test the efficacy of combining hPTH (1-84) and alendronate for treating osteoporosis in postmenopausal women.

238 women were randomized between 55 and 85 years of age to receive either: (1) PTH for 1 year followed by alendronate for 1 year; (2) PTH and alendronate for 1 year followed by alendronate for 1 year; (3) alendronate for 2 years; or (4) PTH for 1 year followed by placebo for 1 year. The primary endpoints are changes in bone mineral density at several sites and changes in biochemical markers.

In addition, we will assess specific biochemical markers of bone turnover (e.g., osteocalcin, deoxypridinoline, N-telopeptide, bone-specific alkaline phosphatase and bone sialoprotein) to determine if they can predict the skeletal response to combination therapy. We will also determine whether PTH positively affects ultrasound measurements in the calcaneus.

Study Type

Interventional

Enrollment (Actual)

238

Phase

  • Phase 2

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

  • United States
    • Maine
      • Bangor, Maine, United States, 04401
        • Maine Center for Osteoporosis
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • University of Minnesota
    • New York
      • New York, New York, United States, 10032
        • Columbia University
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center

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

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Aged between 55 and 85 years
  • Postmenopausal (have not had any menses in the last 5 years)
  • Have a bone mineral density scan (DXA) that can be evaluated at the spine AND at the hip with a T-score equal to or below -2.5 at the spine or the femoral neck or total hip OR T-score equal to or below -2.0 at the spine or the femoral neck or total hip and have at least one of the following risk factors for fracture: (a) age > 65 years; (b) history of postmenopausal fracture (nonvertebral or vertebral); or (c) maternal history of hip fracture
  • Willing and able to self-administer daily injections

Exclusion Criteria:

  • Have used estrogen (oral or patch) for more than 1 month in the last 6 months or more than 12 months in the last 2 years
  • History of more than 12 months of bisphosphonate use ever, or any use (> 4 weeks) within the past 12 months
  • History of rhPTH (recombinant human PTH) use
  • Any major life-threatening illnesses
  • Type 1 or uncontrolled type 2 diabetes mellitus (defined as hemoglobin A1C > 10.0), or currently using insulin
  • Vitamin D level < 15 nanograms/ml
  • History of kidney disease (creatinine > 2.0 mg/dl)
  • Renal insufficiency (creatinine clearance < 40 mg/min)
  • Any history of kidney stones
  • Any history of hypercalciuria or currently have urine calcium/creatinine >300 mg
  • History of hypercalcemia, sarcoidosis, or hyperparathyroidism
  • History of active or treated tuberculosis or other granulomatous disorders
  • History of breast cancer, melanoma, or hematologic malignancy that has required treatment within the last 10 years
  • History of bone cancer or any other metabolic bone disease that has required treatment within the last 10 years
  • History of any other nonskin cancer that has required treatment within the last 10 years
  • History of symptomatic esophageal reflux, achalasia or esophageal stricture
  • Currently taking > 7.5 mg systemic prednisone or equivalent per day
  • Currently using > two puffs, four times/day of inhaled steroids
  • Currently taking anticoagulants or anticonvulsants
  • Have used Calcitonin within the past 3 months
  • Have used Raloxifene in the last 6 months or for more than 12 months in the last 2 years
  • Have used Tamoxifen in the last 6 months or for more than 12 months in the last 2 years
  • Have used fluoride for at least a month within the past 5 years
  • Currently taking > 1000 IU/day vitamin D or vitamin D analogues or metabolites
  • Currently taking thyroid hormone replacement AND have a TSH < 0.1mIU/L

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Participants will receive PTH for 1 year followed by alendronate for 1 year.
Drug: Alendronate
Drug: PTH
Experimental: 2
Participants will receive PTH and alendronate for 1 year followed by alendronate for 1 year.
Drug: Alendronate
Drug: PTH
Experimental: 3
Participants will receive alendronate for 2 years.
Drug: Alendronate
Active Comparator: 4
Participants will receive PTH for 1 year followed by placebo for 1 year.
Drug: PTH

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in bone mineral density at several sites and changes in biochemical markers
Time Frame: Year 2
Year 2

Secondary Outcome Measures

Outcome Measure
Time Frame
Predictive value of specific biochemical markers of bone turnover
Time Frame: Year 2
Year 2

Collaborators and Investigators

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

Sponsor

Dennis Black

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

  • Principal Investigator: Dennis Black, PhD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 1999

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

March 24, 2000

First Submitted That Met QC Criteria

March 24, 2000

First Posted (Estimate)

March 27, 2000

Study Record Updates

Last Update Posted (Estimate)

February 5, 2013

Last Update Submitted That Met QC Criteria

February 4, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N01 AR92245
  • N01AR002245-000 (U.S. NIH Grant/Contract)
  • NIAMS-045

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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