NCT00004406

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 1999

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1999

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 18, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 1999

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
Last Updated

March 25, 2015

Status Verified

January 1, 2000

First QC Date

October 18, 1999

Last Update Submit

March 24, 2015

Conditions

Osteoporosis

Keywords

disease-related problem/conditionosteoporosisrare disease

Interventions

human parathyroid hormoneDRUG

Eligibility Criteria

Age29 Years - 67 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Columbia University College of Physicians and Surgeons

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

OsteoporosisRare Diseases

Interventions

PTH protein, human

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • John Paul Bilezikian

    Columbia University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 18, 1999

First Posted

October 19, 1999

Study Start

October 1, 1999

Study Completion

July 1, 2004

Last Updated

March 25, 2015

Record last verified: 2000-01

Locations

US(1)