Effects of Parathyroid Hormone in Men With Osteoporosis

Osteoporosis Clinical Trial

Official title:

Anabolic Actions of Parathyroid Hormone in Osteoporotic Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000427
• Other study ID #: P50AR044855
• Secondary ID: P50AR044855NIAMS
• Status: Completed
• Phase: Phase 3
• First received: January 18, 2000
• Last updated: December 6, 2013
• Start date: September 1999
• Est. completion date: October 2005

Study information

• Verified date: December 2013
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 46 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Parathyroid hormone

• Alendronate

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Finkelstein JS, Hayes A, Hunzelman JL, Wyland JJ, Lee H, Neer RM. The effects of parathyroid hormone, alendronate, or both in men with osteoporosis. N Engl J Med. 2003 Sep 25;349(13):1216-26. Epub 2003 Sep 20. — View Citation

Finkelstein JS, Klibanski A, Schaefer EH, Hornstein MD, Schiff I, Neer RM. Parathyroid hormone for the prevention of bone loss induced by estrogen deficiency. N Engl J Med. 1994 Dec 15;331(24):1618-23. — View Citation

Finkelstein JS, Leder BZ, Burnett SM, Wyland JJ, Lee H, de la Paz AV, Gibson K, Neer RM. Effects of teriparatide, alendronate, or both on bone turnover in osteoporotic men. J Clin Endocrinol Metab. 2006 Aug;91(8):2882-7. Epub 2006 May 9. — View Citation