Completed

Phase 3
Age: 46Years - 85Years
MALE
ID00000427

Anabolic Actions of Parathyroid Hormone in Osteoporotic Men

Led by Massachusetts General Hospital · Updated on 2013-12-09

81

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

M

Massachusetts General Hospital

Lead Sponsor

N

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Effects of Parathyroid Hormone in Men With Osteoporosis

Who Can Participate

Age: 46Years - 85Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

Trial Site Locations

Total: 1 location

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Status Unknown

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

0

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Published Research Related To This Trial