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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2000 by FDA Office of Orphan Products Development.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Columbia University
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00004406
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: January 2000
History of Changes
  Purpose

OBJECTIVES:

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


Condition Intervention
Osteoporosis
 Drug: human parathyroid hormone

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

Resource links provided by NLM:

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

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

Estimated Enrollment: 36
Study Start Date: October 1999
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.

  Eligibility

Ages Eligible for Study:   29 Years to 67 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

PROTOCOL ENTRY CRITERIA:

--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

Other:

  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004406

Locations
United States, New York
Columbia University College of Physicians and Surgeons Recruiting
New York, New York, United States, 10032
Contact: John Paul Bilezikian     212-305-6238        
Sponsors and Collaborators
FDA Office of Orphan Products Development
Columbia University
Investigators
Study Chair: John Paul Bilezikian Columbia University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004406     History of Changes
Other Study ID Numbers: 199/13293, CPS-CU-FDR001024
Study First Received: October 18, 1999
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013