Effects of Parathyroid Hormone in Men With Osteoporosis

NCT00000427 | Completed Phase 3

• 2 other identifiers: P50AR044855NIAMS-015
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis

Keywords

Parathyroid Hormone (PTH); Alendronate; Bone metabolism; Bone mineral density (BMD); Bone loss; Postmenopausal osteoporosis; Osteoporosis in men

Interventions

Parathyroid hormone DRUG

Alendronate DRUG

Eligibility Criteria

• Age: 46 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (3)

• 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. doi: 10.1056/NEJM199412153312404.

  PMID: 7969342 BACKGROUND

• 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. doi: 10.1056/NEJMoa035725. Epub 2003 Sep 20.

  PMID: 14500805 BACKGROUND

• 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. doi: 10.1210/jc.2006-0190. Epub 2006 May 9.

  PMID: 16684825 RESULT

MeSH Terms

Conditions

Osteoporosis; Bone Diseases, Metabolic; Osteoporosis, Postmenopausal

Interventions

Parathyroid Hormone; Alendronate

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Officials

• Joel S. Finkelstein, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: January 18, 2000
• First Posted: January 19, 2000
• Study Start: September 1, 1999
• Primary Completion: October 1, 2005
• Study Completion: October 1, 2005
• Last Updated: December 9, 2013

Record last verified: 2013-12

Locations

US (1)