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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004406
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : March 25, 2015
Information provided by:
FDA Office of Orphan Products Development

Brief Summary:


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

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: human parathyroid hormone Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Study Start Date : October 1999
Study Completion Date : July 2004

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   29 Years to 67 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004406

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United States, New York
Columbia University College of Physicians and Surgeons
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
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Study Chair: John Paul Bilezikian Columbia University
Layout table for additonal information Identifier: NCT00004406    
Other Study ID Numbers: 199/13293
First Posted: October 19, 1999    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: January 2000
Keywords provided by FDA Office of Orphan Products Development:
disease-related problem/condition
rare disease
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Parathyroid Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents