Osteoporosis, Post-MenopausalPhase 3NCT00543023
A Study of the Treatment of Postmenopausal Women With Osteoporosis
A Phase 3 study testing teriparatide 20 micrograms/day subcutaneous and salmon calcitonin 100 IU/day subcutaneous in people with Osteoporosis, Post-Menopausal, run by Eli Lilly and Company at 2 sites in China.
Trial summary
To compare the effect of treatment with teriparatide with that of salmon calcitonin in postmenopausal women with osteoporosis. Read more about this study
- Who is it for?
- Ages 55 to 85 years, women only
- Conditions the study is for
- Osteoporosis, Post-Menopausal
- What is being tested?
- teriparatide 20 micrograms/day subcutaneous and salmon calcitonin 100 IU/day subcutaneous
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 2 sitesChina
- Study dates
- Jun 2003to Aug 2004
- 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 55 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ambulatory, postmenopausal women aged 55-85 years (at least 3 years have elapsed after menopausal) are included at the time of entry into the trial. They have to be free of severe or chronically disabling conditions other than osteoporosis.
- The patient should have a documented (X-ray) prevalent osteoporotic vertebral fracture or non-vertebral fragility fracture (excluding major trauma). Vertebral deformities will be evaluated on lateral views of the thoracic and lumbar spine. T-12 will be visible on both views so that all vertebrae from T-4 to L-4 can be identified. The radiographs will be performed according to a standardized protocol.
- L-1 through L-4 vertebrae must be without artifacts, multiple vertebral fractures; therefore at least 3 vertebrae should be without fractures, osteophytes, or other abnormalities that would interfere with the analysis of the posterior-anterior lumbar spine BMD measurement. The reading of the BMD, T-score should be in the range of - 2.0 and - 4.0 at least for one of the 2 sites measured (spine or hip).
- The initial lumbar spine and femoral neck BMD assessment and the determination of the patient's eligibility for entry into the screening phase will be made by the central quality assurance for BMD. The central quality assurance center will determine the patient's eligibility for enrollment into the treatment phase. If the L-1 vertebra cannot be analyzed due to artifacts, vertebral fracture, osteophytes, or other abnormalities, that vertebra should be excluded from the analysis.
- Women without language barriers, cooperative and expected to return for all follow-up procedures and who have given informed consent before entering the study and after being informed of the risks, medications, and procedures to be used in the study.
- Normal or clinically insignificant abnormal laboratory values including serum calcium, PTH (1-84) levels and alkaline phosphatase.
Who cannot join
- History of sprue, inflammatory bowel disease, or malabsorption syndrome in the 1 year prior to Visit 2.
- History of nephrolithiasis or urolithiasis in the 2 years prior to Visit 2. Patients with any history of nephro- or urolithiasis must have an appropriate radiology study within 6 months prior to Visit 2. This radiology study, such as an intravenous pyelogram or a supine radiograph of the kidney-ureter-bladder, must document the absence of active disease.
- History of other malignant neoplasms in the 5 years prior to screening, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated. Patients with carcinoma in situ of the uterine cervix treated definitively more than 1 year prior to entry into the study may enter the study.
- Patients who have an increased baseline risk of osteosarcoma: Paget's disease of the bone or unexplained elevations of alkaline phosphatase; patients who have received radiation therapy involving the skeleton.
- History of diseases which affect bone metabolism other than postmenopausal osteoporosis such as Paget's disease, renal osteodystrophy, osteomalacia, any secondary causes of osteoporosis, hypoparathyroidism, hyperparathyroidism, or hyperthyroidism.
Trial locations and contacts
2 sites in 1 country.
China2 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.
Hong Kong
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.
Shatin
About this study
Official title: Comparison of Teriparatide and Calcitonin in the Treatment of Postmenopausal Women With Osteoporosis
To compare the effect of treatment with teriparatide with that of salmon calcitonin in postmenopausal women with osteoporosis.
- Conditions
- Osteoporosis, Post-Menopausal
- Being tested
- teriparatide 20 micrograms/day subcutaneous, salmon calcitonin 100 IU/day subcutaneous
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
teriparatide 20 micrograms/day subcutaneousDrug
Also called LY333334
salmon calcitonin 100 IU/day subcutaneousDrug
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | teriparatide 20 micrograms/day subcutaneous Receives: Drug: teriparatide 20 micrograms/day subcutaneous |
| B | Active comparator | salmon calcitonin 100 IU/day subcutaneous Receives: Drug: salmon calcitonin 100 IU/day subcutaneous |
What is being measured
The primary outcome is the main question the study is designed to answer.
to compare the effect of treatment with teriparatide 20 micrograms/day subcutaneous with that of salmon calcitonin 100 IU/day subcutaneous on change in lumbar spine BMD in postmenopausal women with established osteoporosis.
Secondary outcomes (3)
to compare the effect of treatment with teriparatide 20 micrograms/day with that of calcitonin 100 IU/day on change in femoral neck and total hip BMD in postmenopausal women with established osteoporosis
to compare the effect of treatment with teriparatide 20 micrograms/day with that of calcitonin 100 IU/day on change in biochemical bone markers (bone specific alkaline phosphatase [BSAP] and Osteocalcin) at 3 and 6 months
to assess safety as determined by physical examination, vital signs, clinical laboratory data and reports of adverse events.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2007 (estimated)
- Study startJun 2003
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis, Post-MenopausalStudies 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
- 104 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 - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00543023
- Sponsor's protocol ID
- 6972
- Other IDs
- B3D-AA-GHCF
- Status last verified
- Oct 2007
- First submitted
- 10 Oct 2007
- Last updated
- 12 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Teriparatide and Calcitonin in the Treatment of Postmenopausal Women With Osteoporosis
- ClinicalTrials.gov ID
- NCT00543023
- Acronym / sponsor ID
- 6972
- Conditions
- Osteoporosis, Post-Menopausal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Study completion
- Aug 2004 (actual)
- First posted
- 12 Oct 2007 (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.
To compare the effect of treatment with teriparatide with that of salmon calcitonin in postmenopausal women with 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 20 micrograms/day subcutaneousteriparatide 20 micrograms/day subcutaneous |
| B | Active comparator | Drug: salmon calcitonin 100 IU/day subcutaneoussalmon calcitonin 100 IU/day subcutaneous |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ambulatory, postmenopausal women aged 55-85 years (at least 3 years have elapsed after menopausal) are included at the time of entry into the trial. They have to be free of severe or chronically disabling conditions other than osteoporosis.
- The patient should have a documented (X-ray) prevalent osteoporotic vertebral fracture or non-vertebral fragility fracture (excluding major trauma). Vertebral deformities will be evaluated on lateral views of the thoracic and lumbar spine. T-12 will be visible on both views so that all vertebrae from T-4 to L-4 can be identified. The radiographs will be performed according to a standardized protocol.
- L-1 through L-4 vertebrae must be without artifacts, multiple vertebral fractures; therefore at least 3 vertebrae should be without fractures, osteophytes, or other abnormalities that would interfere with the analysis of the posterior-anterior lumbar spine BMD measurement. The reading of the BMD, T-score should be in the range of - 2.0 and - 4.0 at least for one of the 2 sites measured (spine or hip).
- The initial lumbar spine and femoral neck BMD assessment and the determination of the patient's eligibility for entry into the screening phase will be made by the central quality assurance for BMD. The central quality assurance center will determine the patient's eligibility for enrollment into the treatment phase. If the L-1 vertebra cannot be analyzed due to artifacts, vertebral fracture, osteophytes, or other abnormalities, that vertebra should be excluded from the analysis.
- Women without language barriers, cooperative and expected to return for all follow-up procedures and who have given informed consent before entering the study and after being informed of the risks, medications, and procedures to be used in the study.
Key exclusion criteria (5 listed)
- History of sprue, inflammatory bowel disease, or malabsorption syndrome in the 1 year prior to Visit 2.
- History of nephrolithiasis or urolithiasis in the 2 years prior to Visit 2. Patients with any history of nephro- or urolithiasis must have an appropriate radiology study within 6 months prior to Visit 2. This radiology study, such as an intravenous pyelogram or a supine radiograph of the kidney-ureter-bladder, must document the absence of active disease.
- History of other malignant neoplasms in the 5 years prior to screening, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated. Patients with carcinoma in situ of the uterine cervix treated definitively more than 1 year prior to entry into the study may enter the study.
- Patients who have an increased baseline risk of osteosarcoma: Paget's disease of the bone or unexplained elevations of alkaline phosphatase; patients who have received radiation therapy involving the skeleton.
- History of diseases which affect bone metabolism other than postmenopausal osteoporosis such as Paget's disease, renal osteodystrophy, osteomalacia, any secondary causes of osteoporosis, hypoparathyroidism, hyperparathyroidism, or hyperthyroidism.
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 |
|---|---|---|
| teriparatide 20 micrograms/day subcutaneousAlso: LY333334 | Drug | A |
| salmon calcitonin 100 IU/day subcutaneous | Drug | B |
Primary outcome
to compare the effect of treatment with teriparatide 20 micrograms/day subcutaneous with that of salmon calcitonin 100 IU/day subcutaneous on change in lumbar spine BMD in postmenopausal women with established osteoporosis.
3 secondary outcomes
to compare the effect of treatment with teriparatide 20 micrograms/day with that of calcitonin 100 IU/day on change in femoral neck and total hip BMD in postmenopausal women with established osteoporosis
to compare the effect of treatment with teriparatide 20 micrograms/day with that of calcitonin 100 IU/day on change in biochemical bone markers (bone specific alkaline phosphatase [BSAP] and Osteocalcin) at 3 and 6 months
to assess safety as determined by physical examination, vital signs, clinical laboratory data and reports of adverse events.
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 12 Oct 2007.
- Lilly Clinical Trial RegistryLink provided by the sponsor.
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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 - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
2 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 20 micrograms/day subcutaneous and salmon calcitonin 100 IU/day subcutaneous in people with Osteoporosis, Post-Menopausal, run by Eli Lilly and Company at 2 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 6 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 12 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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?
to compare the effect of treatment with teriparatide 20 micrograms/day subcutaneous with that of salmon calcitonin 100 IU/day subcutaneous on change in lumbar spine BMD in postmenopausal women with established osteoporosis.. 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 12 Oct 2007.