Postmenopausal OsteoporosisNCT02422069
Study of Post Menopausal Osteoporosis (PMO) Among Gynecology Outpatients in Pakistan
An observational study of Postmenopausal Osteoporosis, run by Hoffmann-La Roche at 8 sites in Pakistan.
Trial summary
This observational study will provide an opportunity to document local patterns of susceptibility, patient profile, and usefulness of screening in postmenopausal patients coming to gynecology outpatient clinics in Pakistan. This will also capture the initial management of PMO in diagnosed patients. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Postmenopausal Osteoporosis
- How many people
- 624 participants
- Where
- 8 sitesPakistan
- Study dates
- Apr 2010to Dec 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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study will enroll gynecology outpatients in Pakistan who meet eligibility criteria for observation.
Who may be able to join
- Postmenopausal women
- Age 50 years or greater
Who cannot join
- Previously diagnosed osteoporosis, or receiving treatment for osteoporosis
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Pakistan8 sites
Study site
Islamabad
Study site
Karachi, 74700
Study site
Karachi, 74800
Study site
Karachi
Study site
Lahore, 20021
Study site
Lahore, 54550
Study site
Lahore
Study site
Rawalpindi
About this study
Official title: Registry on Post Menopausal Osteoporosis in Gynecology Setting in Pakistan (REPOSE)
This observational study will provide an opportunity to document local patterns of susceptibility, patient profile, and usefulness of screening in postmenopausal patients coming to gynecology outpatient clinics in Pakistan. This will also capture the initial management of PMO in diagnosed patients. The information gathered will serve as a foundation for developing national guidelines on screening and management of PMO in Pakistan.
- Conditions
- Postmenopausal Osteoporosis
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study Population | Gynecology outpatients who meet eligibility criteria will be enrolled and evaluated for the presence of PMO at screening. Women diagnosed with PMO will complete an additional visit to document the prescribed management plan. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients diagnosed with PMO based upon dual-energy X-ray absorptiometry (DXA) results
Measured: Up to 12 months
Secondary outcomes (1)
Use of various PMO treatment modalities
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study startApr 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal OsteoporosisStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Cross-sectional
- Enrolment
- 624 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02422069
- Sponsor's protocol ID
- ML25212
- Status last verified
- Nov 2016
- First submitted
- 16 Apr 2015
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry on Post Menopausal Osteoporosis in Gynecology Setting in Pakistan (REPOSE)
- ClinicalTrials.gov ID
- NCT02422069
- Acronym / sponsor ID
- ML25212
- Conditions
- Postmenopausal Osteoporosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 624 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 21 Apr 2015 (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 provide an opportunity to document local patterns of susceptibility, patient profile, and usefulness of screening in postmenopausal patients coming to gynecology outpatient clinics in Pakistan. This will also capture the initial management of PMO in diagnosed patients. The information gathered will serve as a foundation for developing national guidelines on screening and management of PMO in Pakistan.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Population | – | –Gynecology outpatients who meet eligibility criteria will be enrolled and evaluated for the presence of PMO at screening. Women diagnosed with PMO will complete an additional visit to document the prescribed management plan. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enroll gynecology outpatients in Pakistan who meet eligibility criteria for observation.
Key inclusion criteria (2 listed)
- Postmenopausal women
- Age 50 years or greater
Key exclusion criteria (1 listed)
- Previously diagnosed osteoporosis, or receiving treatment for osteoporosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of patients diagnosed with PMO based upon dual-energy X-ray absorptiometry (DXA) results
Time frame: Up to 12 months
1 secondary outcome
Use of various PMO treatment modalities
Time frame: Up to 12 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 2 Nov 2016.
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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.
Clinical Trials study director
Hoffmann-La Roche
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postmenopausal Osteoporosis, run by Hoffmann-La Roche at 8 sites in Pakistan.
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 2 inclusion and 1 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Pakistan. 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?
Percentage of patients diagnosed with PMO based upon dual-energy X-ray absorptiometry (DXA) results (time frame: Up to 12 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 2 Nov 2016.