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

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

Sponsors and Collaborators:	FDA Office of Orphan Products Development 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

MedlinePlus related topics:

Osteoporosis

Drug Information available for:

Parathyroid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control

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

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

Keywords provided by FDA Office of Orphan Products Development:

disease-related problem/condition

osteoporosis

rare disease

Study placed in the following topic categories:

Musculoskeletal Diseases

Rare Diseases

Osteoporosis

Bone Diseases, Metabolic

Bone Diseases

ClinicalTrials.gov processed this record on November 30, 2008