Effects of Parathyroid Hormone in Men With Osteoporosis

• Status: Completed
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Treatments: Alendronate; Hormones; Parathyroid Hormone

Criteria

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