Postmenopausal OsteoporosisPhase 4NCT01544894
Clinical Study of Raloxifene and Strontium Ranelate in Postmenopausal Osteoporosis
A Phase 4 study testing Raloxifene and Strontium ranelate in people with Postmenopausal Osteoporosis and Compliance, run by University of Valencia at 1 site in Spain.
Trial summary
The purpose of this study was to compare compliance and efficacy of raloxifene and strontium ranelate in a group of women with postmenopausal osteoporosis. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Osteoporosis, Compliance
- What is being tested?
- Raloxifene and Strontium ranelate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2009to Oct 2011
- Phase
- Phase 4
- 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 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal women with densitometric osteoporosis
Who cannot join
- Secondary osteoporosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Raloxifene and Strontium Ranelate on Compliance and Efficacy in Women With Postmenopausal Osteoporosis
The purpose of this study was to compare compliance and efficacy of raloxifene and strontium ranelate in a group of women with postmenopausal osteoporosis.
Read the detailed description
OBJECTIVE: To compare the performance of raloxifene and strontium rannelate in the management of women with postmenopausal osteoporosis.
DESIGN: Prospective, open label study. SETTING: University hospital menopause unit. PATIENTS: 80 women with postmenopausal osteoporosis were assigned to either raloxifene (60 mg/d) or strontium ranelate (2g/d). Participants were followed for 1 year.
MAIN OUTCOME MEASURE(S): Compliance with each regime. Secondary objectives were parameters of efficacy, including changes in bone mineral density and bone biochemical markers.
- Conditions
- Postmenopausal Osteoporosis, Compliance
- Being tested
- Raloxifene, Strontium ranelate
- Keywords
- Postmenopausal osteoporosis, Compliance, Bone mineral density, Bonemarkers
- Medical subject headings
- Osteoporosis, Postmenopausal, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RaloxifeneDrug
Also called Evista
60 mg/d for one year
Strontium ranelateDrug
Also called Protelos
2 g/d, for one year
| Study group | Role | What they receive |
|---|---|---|
| raloxifene | Active comparator | 60 mg/d for one year. Receives: Drug: Raloxifene |
| strontium ranelate | Active comparator | 2 g/d for one year. Receives: Drug: Strontium ranelate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical study of raloxifene and strontium ranelate in postmenopausal osteoporosis
Primary Outcome measure: compliance. Assessment of compliance assessed two variables, the number of participants maintaining treatment after one year and, among those that completed the one year treatment, the number of them that completed at least 80% of the prescribed dose.
Measured: One year
Secondary outcomes (1)
Clinical study of raloxifene and strontium ranelate in postmenopausal osteoporosis
Secondary outcome measure: efficacy. Efficacy has been assessed by changes in axial bone mineral density (spine and hip) and by changes in biochemical bone markers (C-telopeptides and P1NP in serum).
Axial densitometry has been performed prior to treatment and after completion of the programmed one-year treatment.
Bone markers have been assessed prior to treatment and at the 3rd, 6th and 12th month of treatment.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2012 (estimated)
- Study startSep 2009
- Primary completionOct 2011
- Study completionOct 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 University of ValenciaThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Cano Sanchez, University of Valencia
- Investigators
- Antonio Cano, MD, Study director, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01544894
- Sponsor's protocol ID
- Sr-ral-postmOTP
- Status last verified
- Aug 2012
- First submitted
- 18 Jan 2012
- Last updated
- 3 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Raloxifene and Strontium Ranelate on Compliance and Efficacy in Women With Postmenopausal Osteoporosis
- ClinicalTrials.gov ID
- NCT01544894
- Acronym / sponsor ID
- Sr-ral-postmOTP
- Conditions
- Postmenopausal Osteoporosis, Compliance
- Keywords
- Postmenopausal osteoporosis, Compliance, Bone mineral density, Bonemarkers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 6 Mar 2012 (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.
The purpose of this study was to compare compliance and efficacy of raloxifene and strontium ranelate in a group of women with postmenopausal osteoporosis.
Detailed description
OBJECTIVE: To compare the performance of raloxifene and strontium rannelate in the management of women with postmenopausal osteoporosis.
DESIGN: Prospective, open label study. SETTING: University hospital menopause unit. PATIENTS: 80 women with postmenopausal osteoporosis were assigned to either raloxifene (60 mg/d) or strontium ranelate (2g/d). Participants were followed for 1 year.
MAIN OUTCOME MEASURE(S): Compliance with each regime. Secondary objectives were parameters of efficacy, including changes in bone mineral density and bone biochemical markers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| raloxifene | Active comparator | Drug: Raloxifene60 mg/d for one year. |
| strontium ranelate | Active comparator | Drug: Strontium ranelate2 g/d for one year. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Postmenopausal women with densitometric osteoporosis
Key exclusion criteria (1 listed)
- Secondary osteoporosis
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 |
|---|---|---|
| RaloxifeneAlso: Evista60 mg/d for one year | Drug | raloxifene |
| Strontium ranelateAlso: Protelos2 g/d, for one year | Drug | strontium ranelate |
Primary outcome
Clinical study of raloxifene and strontium ranelate in postmenopausal osteoporosis
Time frame: One year
Primary Outcome measure: compliance. Assessment of compliance assessed two variables, the number of participants maintaining treatment after one year and, among those that completed the one year treatment, the number of them that completed at least 80% of the prescribed dose.
1 secondary outcome
Clinical study of raloxifene and strontium ranelate in postmenopausal osteoporosis
Time frame: One year
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 3 Sep 2012.
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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.
Antonio Cano, MD study director
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Raloxifene and Strontium ranelate in people with Postmenopausal Osteoporosis and Compliance, run by University of Valencia at 1 site in Spain.
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 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 3 Sep 2012. 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 Spain. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Clinical study of raloxifene and strontium ranelate in postmenopausal osteoporosis (time frame: One year). 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 3 Sep 2012.