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Randomized Study of Human Parathyroid Hormone in Middle-Aged Men With Idiopathic Osteoporosis

This study has been completed.
Information provided by:
FDA Office of Orphan Products Development Identifier:
First received: October 18, 1999
Last updated: March 24, 2015
Last verified: January 2000


I. Determine the effect of human parathyroid hormone (1-34) on bone mass in middle-aged men with idiopathic osteoporosis.

Condition Intervention
Drug: human parathyroid hormone

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment: 36
Study Start Date: October 1999
Estimated Study Completion Date: July 2004
Detailed Description:

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. All patients self-administer daily subcutaneous injections of human parathyroid hormone (1-34) or placebo for a period of 2.5 years.

Patients are followed regularly for unacceptable toxicities.

Completion date provided represents the completion date of the grant per OOPD records


Ages Eligible for Study:   29 Years to 67 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


--Disease Characteristics--

Osteoporosis as defined by: Bone mineral density at the lumbar spine or femoral neck that is 2.5 standard deviations below peak bone mass reference value (T score less than -2.5)

No family history of male osteoporosis

No other metabolic bone disease

--Prior/Concurrent Therapy--

Endocrine therapy:

  • No concurrent glucocorticoid therapy
  • No prior steroid use

Surgery: No prior gastrointestinal tract surgery

Other: No prior or concurrent anticonvulsant therapy

--Patient Characteristics--

Hematopoietic: Normal CBC

Hepatic: Normal liver function

Renal: Normal renal function


  • Normal thyroid function
  • Normal adrenal function
  • Normal gonadal status
  • No myeloma or other malignancy
  • No alcoholism, hypercortisolism or diabetes mellitus
  • No gastrointestinal tract disease or disorder associated with malabsorption
  Contacts and Locations
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Please refer to this study by its identifier: NCT00004406

United States, New York
Columbia University College of Physicians and Surgeons
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Study Chair: John Paul Bilezikian Columbia University
  More Information Identifier: NCT00004406     History of Changes
Other Study ID Numbers: 199/13293
Study First Received: October 18, 1999
Last Updated: March 24, 2015

Keywords provided by FDA Office of Orphan Products Development:
disease-related problem/condition
rare disease

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on April 26, 2017