OsteoporosisPhase 3NCT00414973
A Study for Patients With Osteoporosis
A Phase 3 study testing Teriparatide and Salmon Calcitonin in people with Osteoporosis, run by Eli Lilly and Company at 5 sites in China.
Trial summary
The purpose of this study is to compare the effect of injectable teriparatide to intranasal salmon calcitonin on lumbar spine bone mineral density, in the treatment of Chinese patients with established osteoporosis Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Teriparatide and Salmon Calcitonin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 364 participants
- Where
- 5 sitesChina
- Study dates
- Dec 2006to Jul 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of osteoporosis
- No other severe disabling conditions
- Should have at least 1 vertebral or non-vertebral prevalent fracture, and bone mineral density T-score should be less than -2.5
- Ambulatory
- Men (aged 40 to 85 years) or postmenopausal women (aged 55 to 85 years)
Who cannot join
- History of a disease that affects bone metabolism
- History of treatment with any drug that may significantly affect bone metabolism
- History or presence of liver disease
- History or presence of kidney disease
- History of excessive alcohol drinking or drug abuse
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Beijing, 100050
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Chengdu, 610041
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Nanjing, 210029
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Shanghai, 200023
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Wenzhou, 325027
About this study
Official title: Comparison of Teriparatide and Calcitonin in the Treatment of Men and Postmenopausal Women With Osteoporosis
The purpose of this study is to compare the effect of injectable teriparatide to intranasal salmon calcitonin on lumbar spine bone mineral density, in the treatment of Chinese patients with established osteoporosis
- Conditions
- Osteoporosis
- Being tested
- Teriparatide, Salmon Calcitonin
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeriparatideDrug
Also called LY333334, Forteo, Forsteo
Subcutaneous, 20 micrograms/day, 24 weeks
Salmon CalcitoninDrug
Intranasal, 200 International Units (IU)/day, 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Teriparatide |
| B | Active comparator | Not described Receives: Drug: Salmon Calcitonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Postmenopausal Women
Lumbar spine bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline.
Measured: Baseline to 24 weeks
Secondary outcomes (5)
Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Postmenopausal Women
Total hip bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline.
Measured: Baseline to 24 weeks
Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Postmenopausal Women
Measures of serum osteocalcin (nanograms per milliliter). Change = Endpoint minus baseline.
Measured: Baseline to 12 weeks and 24 weeks
Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Men
Lumbar spine bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline.
Measured: Baseline to 24 weeks
Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Men
Total hip bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline.
Measured: Baseline to 24 weeks
Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Men
Measures of serum osteocalcin (nanograms per milliliter). Change = Endpoint minus baseline.
Measured: Baseline to 12 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 364 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00414973
- Sponsor's protocol ID
- 10591
- Other IDs
- B3D-MC-GHDG
- Status last verified
- Oct 2009
- First submitted
- 20 Dec 2006
- Last updated
- 28 Oct 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Teriparatide and Calcitonin in the Treatment of Men and Postmenopausal Women With Osteoporosis
- ClinicalTrials.gov ID
- NCT00414973
- Acronym / sponsor ID
- 10591
- Conditions
- Osteoporosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 364 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 22 Dec 2006 (estimated)
- Results
- Posted 26 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the effect of injectable teriparatide to intranasal salmon calcitonin on lumbar spine bone mineral density, in the treatment of Chinese patients with established osteoporosis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Teriparatide |
| B | Active comparator | Drug: Salmon Calcitonin |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of osteoporosis
- No other severe disabling conditions
- Should have at least 1 vertebral or non-vertebral prevalent fracture, and bone mineral density T-score should be less than -2.5
- Ambulatory
- Men (aged 40 to 85 years) or postmenopausal women (aged 55 to 85 years)
Key exclusion criteria (5 listed)
- History of a disease that affects bone metabolism
- History of treatment with any drug that may significantly affect bone metabolism
- History or presence of liver disease
- History or presence of kidney disease
- History of excessive alcohol drinking or drug abuse
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 |
|---|---|---|
| TeriparatideAlso: LY333334, Forteo, ForsteoSubcutaneous, 20 micrograms/day, 24 weeks | Drug | A |
| Salmon CalcitoninIntranasal, 200 International Units (IU)/day, 24 weeks | Drug | B |
Primary outcome
Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Postmenopausal Women
Time frame: Baseline to 24 weeks
Lumbar spine bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline.
5 secondary outcomes
Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Postmenopausal Women
Time frame: Baseline to 24 weeks
Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Postmenopausal Women
Time frame: Baseline to 12 weeks and 24 weeks
Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Men
Time frame: Baseline to 24 weeks
Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Men
Time frame: Baseline to 24 weeks
Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Men
Time frame: Baseline to 12 weeks and 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
5 sites 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 and Salmon Calcitonin in people with Osteoporosis, run by Eli Lilly and Company at 5 sites in China.
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 5 inclusion and 5 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 28 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. 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.
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?
Yes. Results are posted in the registry (first posted 26 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Postmenopausal Women (time frame: Baseline to 24 weeks). It is what the study was designed to measure, not a finding.
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 28 Oct 2009.