OsteoporosisNCT00004406
Randomized Study of Human Parathyroid Hormone in Middle-Aged Men With Idiopathic Osteoporosis
A study testing human parathyroid hormone in people with Osteoporosis, run by Columbia University at 1 site in United States.
Trial summary
OBJECTIVES: I. Determine the effect of human parathyroid hormone (1-34) on bone mass in middle-aged men with idiopathic osteoporosis. Read more about this study
- Who is it for?
- Ages 29 to 67 years, men only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- human parathyroid hormone
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1999to Jul 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 29 to 67 years
- Men only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University College of Physicians and Surgeons
New York, New York, 10032
About this study
OBJECTIVES:
- Determine the effect of human parathyroid hormone (1-34) on bone mass in middle-aged men with idiopathic osteoporosis.
Read the 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
- Conditions
- Osteoporosis
- Being tested
- human parathyroid hormone
- Keywords
- disease-related problem/condition, osteoporosis, rare disease
- Medical subject headings
- Osteoporosis, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human parathyroid hormoneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 1999 (estimated)
- Study startOct 1999
- Study completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Investigators
- John Paul Bilezikian, Study chair, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004406
- Sponsor's protocol ID
- 199/13293
- Other IDs
- CPS-CU-FDR001024
- Status last verified
- Jan 2000
- First submitted
- 18 Oct 1999
- Last updated
- 25 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Human Parathyroid Hormone in Middle-Aged Men With Idiopathic Osteoporosis
- ClinicalTrials.gov ID
- NCT00004406
- Acronym / sponsor ID
- 199/13293
- Conditions
- Osteoporosis
- Keywords
- disease-related problem/condition, osteoporosis, rare disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Oct 1999
- Study completion
- Jul 2004
- First posted
- 19 Oct 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVES:
- Determine the effect of human parathyroid hormone (1-34) on bone mass in middle-aged men with idiopathic osteoporosis.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 29 to 67 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| human parathyroid hormone | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Paul Bilezikian study chair
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing human parathyroid hormone in people with Osteoporosis, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2015.