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

This study is currently recruiting participants.

Verified by FDA Office of Orphan Products Development, January 2000

First Received: October 18, 1999 Last Updated: June 23, 2005 History of Changes

Sponsor:	FDA Office of Orphan Products Development
Collaborator:	Columbia University
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00004406

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:	Treatment, Randomized, Double-Blind, Placebo Control

Resource links provided by NLM:

MedlinePlus related topics: Osteoporosis

Drug Information available for: Parathyroid

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

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

Musculoskeletal Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Osteoporosis

Bone Diseases, Metabolic
Hormones
Bone Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 25, 2009