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Effects of Parathyroid Hormone in Men With Osteoporosis

This study has been completed.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Joel S. Finkelstein, MD, Massachusetts General Hospital Identifier:
First received: January 18, 2000
Last updated: December 6, 2013
Last verified: December 2013
Alendronate is a drug that blocks or reduces bone loss, while parathyroid hormone (PTH) stimulates the formation of new bone. The purpose of this study is to compare the bone-building effects of PTH alone, alendronate alone, and both PTH and alendronate in men with osteoporosis over a two-and-a-half year period.

Condition Intervention Phase
Osteoporosis Drug: Parathyroid hormone Drug: Alendronate Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Anabolic Actions of Parathyroid Hormone in Osteoporotic Men

Resource links provided by NLM:

Further study details as provided by Joel S. Finkelstein, MD, Massachusetts General Hospital:

Estimated Enrollment: 81
Study Start Date: September 1999
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Detailed Description:

Osteoporosis causes bones to weaken and break more easily. Alendronate is used to treat or prevent osteoporosis. PTH is a protein hormone that increases the calcium and phosphorus release from bone, leading to formation of new bone. This study will examine the changes in bone density measured at multiple places in the skeleton and changes in chemicals in the body that indicate bone breakdown and bone formation. The study will indicate whether some breakdown of bone is required for PTH to have an overall bone-building effect in men.

Participants will be randomly assigned to receive PTH alone by daily injection under the skin, alendronate alone taken by mouth, or both PTH and alendronate. The study will last 2.5 years. All participants will receive some form of treatment for osteoporosis. Blood, urine, and bone density tests will be performed at 6-month intervals. During the first 6 months, participants will come in for additional study visits.

Participants who complete the initial 2.5 years of their assigned treatment will be eligible for a 12 month extension to monitor bone density and bone turnover after PTH is stopped. Participants who were receiving alendronate will continue taking alendronate. The goal of this extension is to determine what happens to bone density and turnover after PTH is stopped and whether alendronate is needed to prevent loss of PTH-induced bone gain.

Participants who complete the 12 month extension while on their assigned treatment will be eligible for a second 12 month extension in which all participants receive PTH therapy. Participants who have been receiving alendronate continue taking alendronate. The goal of the second extension is to determine if responsiveness to PTH is enhanced by a 12 month suspension of PTH treatment.


Ages Eligible for Study:   46 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Bone density of the spine or femoral neck two standard deviations below the mean of young adult men
  • Normal renal and liver function tests, normal serum testosterone level, normal vitamin D and PTH levels

Exclusion Criteria:

  • Significant cardiac, renal, hepatic, or malignant disease.
  • Disorders (e.g., Paget's disease, hyperthyroidism, hyperparathyroidism) or drugs (e.g., steroids, anticonvulsants, lithium, bisphosphonates, calcitonin, fluoride) known to affect bone metabolism
  • Active peptic ulcer disease or severe reflux
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Please refer to this study by its identifier: NCT00000427

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator: Joel S. Finkelstein, MD Massachusetts General Hospital
  More Information

Responsible Party: Joel S. Finkelstein, MD, Associate Professor of Medicine, Massachusetts General Hospital Identifier: NCT00000427     History of Changes
Other Study ID Numbers: P50AR044855 ( U.S. NIH Grant/Contract )
Study First Received: January 18, 2000
Last Updated: December 6, 2013

Keywords provided by Joel S. Finkelstein, MD, Massachusetts General Hospital:
Parathyroid Hormone (PTH)
Bone metabolism
Bone mineral density (BMD)
Bone loss
Postmenopausal osteoporosis
Osteoporosis in men

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on September 20, 2017