OsteopeniaPhase 3NCT00065637
Once Weekly Parathyroid Hormone for Osteoporosis
A Phase 3 study testing Teriparatide in people with Osteopenia and Osteoporosis, run by University of California, San Francisco at 1 site in United States.
Trial summary
Daily parathyroid hormone (PTH) is approved by the FDA for the treatment of osteoporosis. This study will evaluate the safety and effectiveness of PTH when given once a week. Read more about this study
- Who is it for?
- Ages 45 to 70 years, women only
- Conditions the study is for
- Osteopenia, Osteoporosis
- What is being tested?
- Teriparatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to Sep 2005
- Phase
- Phase 3
- 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 45 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Bone mineral density scan with a T-score between -1 and -2
- Willing to self-administer injections
- Postmenopausal
Who cannot join
- Medications to treat osteoporosis, including: hormone replacement therapy for more than one month in the 6 months prior to study, or for more than 12 months in the 2 years prior to study; alendronate, risedronate, or etidronate for more than 1 year anytime prior to study; calcitonin in the 3 months prior to study; taken raloxifene or tamoxifen in the last 6 months or for more than 1 year in the 2 years prior to study; fluoride for more than 1 month in the 5 years prior to study
- Bone fracture since menopause
- Femoral neck T-score below -2 AND lumbar spine T-score below -2.5 OR femoral neck T-score below -2.5 AND T-scores of both total hip and lumbar spine below -2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PTH Once Weekly Research (POWR)
Daily parathyroid hormone (PTH) is approved by the FDA for the treatment of osteoporosis. This study will evaluate the safety and effectiveness of PTH when given once a week.
Read the detailed description
In osteoporosis, skeletal bone mass and strength are so reduced that fractures occur after only modest levels of mechanical stress that would not harm normal bone. Fractures of the hip, spine, and wrists are most typical, though fractures of the ribs, pelvis, and humerus also occur. Research has shown that hip fractures cause a 10% to 20% increase in mortality, and the cost of all osteoporotic fractures is estimated to be $6.14 billion in health care costs and lost earnings per year. The most common form of osteoporosis is postmenopausal osteoporosis. A reduction in bone mineral density of approximately 1% to 2% per year is observed for the first 3 to 5 years after the onset of menopause, then 0.5% to 1% per year thereafter.
PTH was recently approved by the FDA as a daily treatment for osteoporosis. However, PTH must be self-injected, is very expensive, and has been associated with worrisome side effects. The currently approved formulation of daily PTH self-injections is practical for only a small proportion of people with osteoporosis. A once weekly formulation could significantly decrease cost, difficulty of administration, and risks and side effects associated with daily use of PTH. A once weekly injection by a caregiver would also make PTH accessible to populations for whom daily self-injection may not be practical, such as the very elderly or those in assisted living or nursing homes. This study will evaluate the safety and effectiveness of once weekly PTH dosing for women with osteoporosis.
Women will be randomized to receive either PTH or placebo. Women will self-administer injections daily for 4 weeks, then once weekly for 48 weeks. All women will receive calcium and vitamin D supplements daily. Women will visit the clinic six times over the course of a year and will provide urine and blood samples at each visit. Bone mineral density will be measured at 6 and 12 months.
- Conditions
- Osteopenia, Osteoporosis
- Being tested
- Teriparatide, Placebo teriparatide
- Medical subject headings
- Bone Diseases, Metabolic, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeriparatideDrug
Synthetic human parathyroid hormone
Placebo teriparatideDrug
Placebo injections
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Women will self-administer PTH injections daily for 4 weeks, then once weekly for 48 weeks Receives: Drug: Teriparatide |
| 2 | Placebo comparator | Women will self-administer placebo injections daily for 4 weeks, then once weekly for 48 weeks Receives: Drug: Placebo teriparatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density
Measured: Months 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2003 (estimated)
- Study startDec 2003
- Primary completionSep 2005
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteopeniaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Clifford Rosen, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00065637
- Sponsor's protocol ID
- N01 AR32268
- Other IDs
- N01AR002245-000, NIAMS-092
- Status last verified
- Feb 2013
- First submitted
- 29 Jul 2003
- Last updated
- 5 Feb 2013
- Results posted
- No
Publications
Brown SA, Rosen CJ. Osteoporosis. Med Clin North Am. 2003 Sep;87(5):1039-63. doi: 10.1016/s0025-7125(03)00065-8.
PubMed 14621330Rosen CJ. The cellular and clinical parameters of anabolic therapy for osteoporosis. Crit Rev Eukaryot Gene Expr. 2003;13(1):25-38. doi: 10.1615/critreveukaryotgeneexpr.v13.i1.30.
PubMed 12839095
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PTH Once Weekly Research (POWR)
- ClinicalTrials.gov ID
- NCT00065637
- Acronym / sponsor ID
- N01 AR32268
- Conditions
- Osteopenia, Osteoporosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Dec 2003
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 30 Jul 2003 (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.
Daily parathyroid hormone (PTH) is approved by the FDA for the treatment of osteoporosis. This study will evaluate the safety and effectiveness of PTH when given once a week.
Detailed description
In osteoporosis, skeletal bone mass and strength are so reduced that fractures occur after only modest levels of mechanical stress that would not harm normal bone. Fractures of the hip, spine, and wrists are most typical, though fractures of the ribs, pelvis, and humerus also occur. Research has shown that hip fractures cause a 10% to 20% increase in mortality, and the cost of all osteoporotic fractures is estimated to be $6.14 billion in health care costs and lost earnings per year. The most common form of osteoporosis is postmenopausal osteoporosis. A reduction in bone mineral density of approximately 1% to 2% per year is observed for the first 3 to 5 years after the onset of menopause, then 0.5% to 1% per year thereafter.
PTH was recently approved by the FDA as a daily treatment for osteoporosis. However, PTH must be self-injected, is very expensive, and has been associated with worrisome side effects. The currently approved formulation of daily PTH self-injections is practical for only a small proportion of people with osteoporosis. A once weekly formulation could significantly decrease cost, difficulty of administration, and risks and side effects associated with daily use of PTH. A once weekly injection by a caregiver would also make PTH accessible to populations for whom daily self-injection may not be practical, such as the very elderly or those in assisted living or nursing homes. This study will evaluate the safety and effectiveness of once weekly PTH dosing for women with osteoporosis.
Women will be randomized to receive either PTH or placebo. Women will self-administer injections daily for 4 weeks, then once weekly for 48 weeks. All women will receive calcium and vitamin D supplements daily. Women will visit the clinic six times over the course of a year and will provide urine and blood samples at each visit. Bone mineral density will be measured at 6 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: TeriparatideWomen will self-administer PTH injections daily for 4 weeks, then once weekly for 48 weeks |
| 2 | Placebo comparator | Drug: Placebo teriparatideWomen will self-administer placebo injections daily for 4 weeks, then once weekly for 48 weeks |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Bone mineral density scan with a T-score between -1 and -2
- Willing to self-administer injections
- Postmenopausal
Key exclusion criteria (3 listed)
- Medications to treat osteoporosis, including: hormone replacement therapy for more than one month in the 6 months prior to study, or for more than 12 months in the 2 years prior to study; alendronate, risedronate, or etidronate for more than 1 year anytime prior to study; calcitonin in the 3 months prior to study; taken raloxifene or tamoxifen in the last 6 months or for more than 1 year in the 2 years prior to study; fluoride for more than 1 month in the 5 years prior to study
- Bone fracture since menopause
- Femoral neck T-score below -2 AND lumbar spine T-score below -2.5 OR femoral neck T-score below -2.5 AND T-scores of both total hip and lumbar spine below -2
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 |
|---|---|---|
| TeriparatideSynthetic human parathyroid hormone | Drug | 1 |
| Placebo teriparatidePlacebo injections | Drug | 2 |
Primary outcome
Bone mineral density
Time frame: Months 6 and 12
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 5 Feb 2013.
- Background: PubMed 14621330Brown SA, Rosen CJ. Osteoporosis. Med Clin North Am. 2003 Sep;87(5):1039-63. doi: 10.1016/s0025-7125(03)00065-8.
- Background: PubMed 12839095Rosen CJ. The cellular and clinical parameters of anabolic therapy for osteoporosis. Crit Rev Eukaryot Gene Expr. 2003;13(1):25-38. doi: 10.1615/critreveukaryotgeneexpr.v13.i1.30.
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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.
Clifford Rosen, MD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Teriparatide in people with Osteopenia and Osteoporosis, run by University of California, San Francisco 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?
The sponsor lists 3 inclusion and 3 exclusion criteria. 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 5 Feb 2013. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Bone mineral density (time frame: Months 6 and 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00065637, which also lists 2 linked publications.
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 5 Feb 2013.