Alendronate and/or Parathyroid Hormone for Osteoporosis

December 6, 2013 updated by: Robert M. Neer, MD, Massachusetts General Hospital

Bone Formation-Resorption Coupling and Osteoporosis

This study looks at the effects of two medications, alendronate and parathyroid hormone, on bone mass and on bone formation and bone breakdown in women with osteoporosis. We will randomly select postmenopausal women who have osteoporosis to receive laboratory-produced human parathyroid hormone (hPTH), or alendronate, or both for 2.5 years. Study participants will return to the study center periodically to have their bone mass measured and to give blood and urine samples for tests of bone formation and breakdown and for other laboratory tests. Those who complete the study are eligible for one or two 12 month extension studies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, prospective, open-label study in which osteoporotic postmenopausal women self-administer synthetic hPTH-(1-34), alendronate, or both, every day for 2.5 years. Participants initially come to Massachusetts General Hospital once a month, and subsequently once every 3-6 months, for measurements of serum and urine indices of bone formation and resorption, serum and urine toxicity tests, and DXA/QCT measurements of bone mass. One-third of the participants take hPTH-(1-34) daily, one-third take alendronate once daily, and one-third take both daily (Phase A, months 0-30).

Participants who complete Phase A are eligible for a 12 month extension study (Phase B, months 30-42), during which any alendronate treatment is continued without change and any hPTH 1-34 treatment is stopped.

Participants who complete Phase B are eligible for a second 12 month extension study (Phase C, months 42-54), during which any alendronate treatment is continued without change and every participant takes hPTH 1-34.

During Phases B and C, these participants come to Massachusetts General Hospital once every 6 months for measurements of serum and urine indices of bone formation and resorption, serum and urine toxicity tests, and DXA/QCT measurements of bone mass.

Study Type

Interventional

Enrollment (Actual)

176

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
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

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 to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Lumbar spine or hip BMD T-score less than or equal to minus 2.0
  • Postmenopausal at least 5 years
  • Fully ambulatory
  • Able to give informed consent

Exclusion Criteria:

  • No concurrent illnesses that cause bone loss
  • No recent drug treatment for osteoporosis
  • No recent fracture

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: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PTH
Human parathyroid hormone [hPTH-(1-34)]
Drug: Human parathyroid hormone [hPTH-(1-34)]
37 mcg once daily by self-administered sc injection
Other Names:
  • teriparatide
ACTIVE_COMPARATOR: ALN
Alendronate
Drug: alendronate
70 mg/week by oral route
Other Names:
  • Fosamax
EXPERIMENTAL: PTH+ALN
Human parathyroid hormone [hPTH-(1-34)] plus alendronate
Drug: Human parathyroid hormone [hPTH-(1-34)]
37 mcg once daily by self-administered sc injection
Other Names:
  • teriparatide
Drug: alendronate
70 mg/week by oral route
Other Names:
  • Fosamax

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in spine bone mineral density
Time Frame: study months 30 (phase A), 42 (phase B), 54 (phase C)
study months 30 (phase A), 42 (phase B), 54 (phase C)

Secondary Outcome Measures

Outcome Measure
Time Frame
change in hip bone mineral density
Time Frame: study months 30 (phase A), 42 (phase B), 54 (phase C)
study months 30 (phase A), 42 (phase B), 54 (phase C)
change in forearm bone mineral density
Time Frame: study months 30 (phase A), 42 (phase B), 54 (phase C)
study months 30 (phase A), 42 (phase B), 54 (phase C)
change in total body bone mineral
Time Frame: study months 30 (phase A), 42 (phase B), 54 (phase C)
study months 30 (phase A), 42 (phase B), 54 (phase C)
change in femoral shaft bone mineral density
Time Frame: study months 30 (phase A), 42 (phase B), 54 (phase C)
study months 30 (phase A), 42 (phase B), 54 (phase C)
change in serum PINP
Time Frame: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)
study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)
change in serum osteocalcin
Time Frame: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)
study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)
change in serum NTX
Time Frame: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)
study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)
incidence of hypercalcemia
Time Frame: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)
study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)
incidence of hypercalciuria
Time Frame: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)
study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)
incidence of symptoms
Time Frame: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)
study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)

Collaborators and Investigators

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

Sponsor

Massachusetts General Hospital

Collaborators

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

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

Helpful Links

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

August 1, 1999

Primary Completion (ACTUAL)

April 1, 2006

Study Completion (ACTUAL)

June 1, 2006

Study Registration Dates

First Submitted

November 3, 1999

First Submitted That Met QC Criteria

November 3, 1999

First Posted (ESTIMATE)

November 4, 1999

Study Record Updates

Last Update Posted (ESTIMATE)

December 9, 2013

Last Update Submitted That Met QC Criteria

December 6, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P50 AR44855 NIAMS-023
  • P50AR044855 (NIH)

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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