Effects of Parathyroid Hormone in Men With Osteoporosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00000427
Recruitment Status : Completed
First Posted : January 19, 2000
Last Update Posted : December 9, 2013
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Joel S. Finkelstein, MD, Massachusetts General Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Osteoporosis Drug: Parathyroid hormone Drug: Alendronate Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Anabolic Actions of Parathyroid Hormone in Osteoporotic Men
Study Start Date : September 1999
Actual Primary Completion Date : October 2005
Actual Study Completion Date : October 2005

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Ages Eligible for Study:   46 Years to 85 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Publications of Results:
Other Publications:
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 )
P50AR044855 ( U.S. NIH Grant/Contract )
First Posted: January 19, 2000    Key Record Dates
Last Update Posted: December 9, 2013
Last Verified: December 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
Metabolic Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents