Osteoporosis, PostmenopausalISSONCT00696644
A Study for Teriparatide in Severe Osteoporosis
An observational study of Osteoporosis, Postmenopausal and Osteoporosis, run by Eli Lilly and Company at 1 site in Italy.
Trial summary
This observational study will evaluate the incidence of new vertebral and non vertebral fragility fractures in patients with severe osteoporosis treated with anabolic drugs. This study will also evaluate BMD, compliance to treatment, back pain and the health-related quality of life. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Osteoporosis, Postmenopausal, Osteoporosis
- What is being tested?
- Teriparatide
- Type of treatment
- Injection or infusion
- How many people
- 794 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2008to Apr 2011
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- Postmenopausal women and men older than 21 years affected by severe osteoporosis with an incidental vertebral or hip fracture during treatment with an antiresorptive, or having 3 or more severe vertebral fractures or having 2 severe vertebral fractures and an historical hip fracture.
Who cannot join
- Any contraindication for the use of antiosteoporotic drug
- Premenopausal women or men younger than 21 years
Trial locations and contacts
1 site in 1 country.
Italy1 site
For additional information regarding investigative sites for this study, 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.
Valeggio sul Mincio, Verona, 36067
About this study
Official title: An Italian Observational Study to Evaluate Fracture Outcomes, Compliance to Treatment, Back Pain, Health-related Quality of Life in Patients With Severe Osteoporosis Treated According to Common Clinical Practice
This observational study will evaluate the incidence of new vertebral and non vertebral fragility fractures in patients with severe osteoporosis treated with anabolic drugs. This study will also evaluate BMD, compliance to treatment, back pain and the health-related quality of life.
Read the detailed description
The participants should be treated with anabolic therapy for osteoporosis (Teriparatide or PTH 1-84) for 18 months and should be followed up for subsequent 6 months. The treatment is expected to improve bone mineral density, back pain and reduce the risk of new fractures due to osteoporosis. The outcomes will be evaluated by bone densitometry at the lumbar spine and femoral neck, by standard radiographs, by measurements of bone formation marker (P1NP) and by questionnaires on back pain and quality of life. Postmenopausal women and men over 21 years old may be included if they have:
- at least 3 severe vertebral fractures
- 2 severe vertebral fractures and 1 hip fracture
- an incidental vertebral fracture or an hip fracture during treatment with antiresorptives prescribed for at least 12 months.
- Conditions
- Osteoporosis, Postmenopausal, Osteoporosis
- Being tested
- Teriparatide
- Medical subject headings
- Osteoporosis, Postmenopausal, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeriparatideDrug
20 mcg daily subcutaneous for 18 months.
| Study group | Role | What they receive |
|---|---|---|
| Patients with severe osteoporosis | Postmenopausal women and men aged > 21 years old affected by severe osteoporosis Receives: Drug: Teriparatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of any osteoporotic fractures in the first 24 months from the initiation of anabolic medication.
Measured: From 0 to 24 months
Secondary outcomes (7)
Treatment compliance
Measured: From 0 to 24 months
Reason of discontinuation
Measured: From 0 to 24 months
BMD changes (lumbar and femoral BMD)
Measured: From 0 to 24 months
Changes in bone turnover marker measured by P1NP
Measured: From 0 to 24 months
Quality of Life (measured by EQ-5D of EuroQol Group)
Measured: From 0 to 24 months
Back Pain measured by visual analogue scale and back pain questionnaire
Measured: From 0 to 24 months
Assessment of motor performance and chair rising test
Measured: From 0 to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis, PostmenopausalStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 794 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
- NCT00696644
- Sponsor's protocol ID
- 12456
- Other IDs
- B3D-IT-B014
- Acronym
- ISSO
- Status last verified
- May 2011
- First submitted
- 11 Jun 2008
- Last updated
- 9 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Italian Observational Study to Evaluate Fracture Outcomes, Compliance to Treatment, Back Pain, Health-related Quality of Life in Patients With Severe Osteoporosis Treated According to Common Clinical Practice
- ClinicalTrials.gov ID
- NCT00696644
- Acronym / sponsor ID
- ISSO / 12456
- Conditions
- Osteoporosis, Postmenopausal, Osteoporosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 794 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 13 Jun 2008 (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.
This observational study will evaluate the incidence of new vertebral and non vertebral fragility fractures in patients with severe osteoporosis treated with anabolic drugs. This study will also evaluate BMD, compliance to treatment, back pain and the health-related quality of life.
Detailed description
The participants should be treated with anabolic therapy for osteoporosis (Teriparatide or PTH 1-84) for 18 months and should be followed up for subsequent 6 months. The treatment is expected to improve bone mineral density, back pain and reduce the risk of new fractures due to osteoporosis. The outcomes will be evaluated by bone densitometry at the lumbar spine and femoral neck, by standard radiographs, by measurements of bone formation marker (P1NP) and by questionnaires on back pain and quality of life. Postmenopausal women and men over 21 years old may be included if they have:
- at least 3 severe vertebral fractures
- 2 severe vertebral fractures and 1 hip fracture
- an incidental vertebral fracture or an hip fracture during treatment with antiresorptives prescribed for at least 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with severe osteoporosis | – | Drug: TeriparatidePostmenopausal women and men aged > 21 years old affected by severe osteoporosis |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (1 listed)
- Postmenopausal women and men older than 21 years affected by severe osteoporosis with an incidental vertebral or hip fracture during treatment with an antiresorptive, or having 3 or more severe vertebral fractures or having 2 severe vertebral fractures and an historical hip fracture.
Key exclusion criteria (2 listed)
- Any contraindication for the use of antiosteoporotic drug
- Premenopausal women or men younger than 21 years
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 |
|---|---|---|
| Teriparatide20 mcg daily subcutaneous for 18 months. | Drug | Patients with severe osteoporosis |
Primary outcome
Incidence of any osteoporotic fractures in the first 24 months from the initiation of anabolic medication.
Time frame: From 0 to 24 months
7 secondary outcomes
Treatment compliance
Time frame: From 0 to 24 months
Reason of discontinuation
Time frame: From 0 to 24 months
BMD changes (lumbar and femoral BMD)
Time frame: From 0 to 24 months
Changes in bone turnover marker measured by P1NP
Time frame: From 0 to 24 months
Quality of Life (measured by EQ-5D of EuroQol Group)
Time frame: From 0 to 24 months
Back Pain measured by visual analogue scale and back pain questionnaire
Time frame: From 0 to 24 months
Assessment of motor performance and chair rising test
Time frame: From 0 to 24 months
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 9 May 2011.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, Postmenopausal and Osteoporosis, run by Eli Lilly and Company at 1 site in Italy.
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 1 inclusion and 2 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 9 May 2011. 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 Italy. 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.
What does the primary outcome measure?
Incidence of any osteoporotic fractures in the first 24 months from the initiation of anabolic medication. (time frame: From 0 to 24 months). 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 9 May 2011.