Osteoporosis, PostmenopausalPhase 4NCT02090400
Switching From Oral Bisphosphonates to Bazedoxifene to Evaluate Effects on Bone Mineral Density in Postmenopausal Women
A Phase 4 study testing Bazedoxifene and Calcium/Vit D in people with Osteoporosis, Postmenopausal, run by Instituto Palacios at 3 sites in Spain.
Trial summary
The aim of this study is see the changes in bone mineral density after discontinuation or stop the use of bisphosphonates and make the switch to bazedoxifene). Read more about this study
- Who is it for?
- Ages 55 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Postmenopausal
- What is being tested?
- Bazedoxifene and Calcium/Vit D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 3 sitesSpain
- Study dates
- May 2013to Jul 2015
- 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 55 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ambulatory postmenopausal women 55 years or older at screening
- Have received daily, weekly or monthly oral bisphosphonates at least for 3 years and treatment change is indicated (not responses to bisphosphonates, for bad tolerability or for the potential risk of side effects in a long term treatment with bisphosphonates-indicated by Federal Drug Administration, European Medicines Agency.
- Subjects has stop bisphosphonates therapy no more than one month before screening visit for subjects in daily or weekly bisphosphonates
- Subjects has stop bisphosphonates therapy no more than two months before screening visit for subjects in monthly bisphosphonates
- Screening T-score at the lumbar spine ≤ -2.0 to -4.0 by Dual X ray Absorptiometry (DXA) scan
- At least 2 lumbar vertebrae must be evaluable by DXA
- Al least one hip must be evaluable by DXA (for secondary objectives)
Who cannot join
- Any disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
- Current use of medication prescribed for osteoporosis other than oral bisphosphonates
- Subjects who had received intravenous bisphosphonates or fluoride (except for dental treatment)
- Subjects who had received any Selective Estrogens Receptor Modulator (SERM), anabolic steroids, systemic hormone replacement, calcitonin or calcitriol within 3 months.
- Subjects who had received strontium ranelate, parathyroid hormone (PTH) or PTH derivates within 1 year.
- Hyper or hypothyroidism, current hyper or hypoparathyroidism
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- History of Venous Thromboembolism Event (VTE)
- Significantly impaired renal function as determined by estimated Glomerular Filtration Rate less 35 mL/min
- Hyper or hypocalcemia
- Vitamin D deficiency (serum 25 (OH) vit D level < 20 ng/mL (< 50nmol/L)
- Any condition that could result in impaired calcium metabolism or metabolic bone disease that could interfere with interpretation findings
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Gabinete Médico Velázquez
Madrid, Madrid, 28001
Instituto Palacios
Madrid, Madrid, 28009
Instituto de Ginecología EGR
Madrid, Madrid, 28023
About this study
Official title: Multi-centre, Randomized, Open Label Trial to Evaluate the Effects of Switching to Bazedoxifene in Comparison With Switching to Calcium and Vitamin D in Postmenopausal Women Previously Treated With Bisphosphonates
The aim of this study is see the changes in bone mineral density after discontinuation or stop the use of bisphosphonates and make the switch to bazedoxifene).
Read the detailed description
The primary hypothesis is: "Comparing to control group (Calcium+VitD), Bazedoxifene group (20mg daily+ calcium+VitD) is efficient in reducing BMD in spine at 12 months of treatment. in postmenopausal women switching from daily, weekly or monthly bisphosphonates therapy. It is a non-inferiority study of Bazedoxifene compared to biphosphonates, being each patient its own control from the baseline. It is a superiority study of Bazedoxifene compared to Calcium+VitD.
Taking into account the difference in the percentage change observed in the total BMD of the spine during 12 months in those patients treated with Bazedoxifene+Ca+VitD at least 110 patients should be included, 55 in each arm of treatment.
This simple size is going to allow us to detect the differences in the percentage change observed in the total BMD of the spine during 12 months between the two treatment arms, being the same or over 0.25%, with a significance level of 95%, an 80% power. It is estimated a standard deviation of 0.5%, and a 10% lost follow-up rate.
- Conditions
- Osteoporosis, Postmenopausal
- Being tested
- Bazedoxifene, Calcium/Vit D
- Keywords
- Women, Osteoporosis, Postmenopausal, Bazedoxifene, BMD
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BazedoxifeneDrug
Also called Conbriza
20 mg Oral daily for 12 months
Calcium/Vit DDrug
Also called Ostine
Calcium 500 mg / 400 IU Vit D
| Study group | Role | What they receive |
|---|---|---|
| Bazedoxifene & Calcium/Vit D | Other | Bazedoxifene 20mg oral once a day and calcium 500mg and 400 IU vitamin D (OSTINE) Receives: Drug: Bazedoxifene; Drug: Calcium/Vit D |
| Calcium/Vit D | Other | Calcium 500mg and 400 IU vitamin D (OSTINE )daily. Receives: Drug: Calcium/Vit D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbar Spine Bone Mineral Density (BMD)
To evaluate the change in Lumbar Spine Bone Mineral Density (BMD)
Measured: 12 months
Secondary outcomes (4)
Bone Turnover Markers (BTM´s) carboxy-terminal collagen crosslinks (CTX) and 1 procollagen N-terminal (P1NP)
To evaluate the effects of switching to Bazedoxifene 20mg in comparison with switching to calcium 500mg and 400 International Units (IU) vitamin D (OSTINE) daily on BTM's CTX and P1NP
Measured: 6 and 12 months from baseline
BMD at the femoral neck
To evaluate the effects of switching to Bazedoxifene 20mg in comparison with switching to calcium 500mg and 400 IU vitamin D (OSTINE) daily on BMD at the femoral neck
Measured: 6 and 12 months from baseline
BMD at total hip
To evaluate the effects of switching to Bazedoxifene 20mg in comparison with switching to calcium 500mg and 400 IU vitamin D (OSTINE) daily on BMD at total hip
Measured: 6 and 12 months from baseline
Mammography
Changes in Mammography at12 months from baseline in the Breast Imaging Report and Database System (BI-RADS) classification
Measured: 12 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2014 (estimated)
- Study startMay 2013
- Primary completionJul 2015
- Study completionJul 2015
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.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Palacios
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Santiago Palacios, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02090400
- Sponsor's protocol ID
- IP-2012-01
- Other IDs
- 2012-003131-28
- Status last verified
- Sep 2015
- First submitted
- 11 Mar 2014
- Last updated
- 9 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-centre, Randomized, Open Label Trial to Evaluate the Effects of Switching to Bazedoxifene in Comparison With Switching to Calcium and Vitamin D in Postmenopausal Women Previously Treated With Bisphosphonates
- ClinicalTrials.gov ID
- NCT02090400
- Acronym / sponsor ID
- IP-2012-01
- Conditions
- Osteoporosis, Postmenopausal
- Keywords
- Women, Osteoporosis, Postmenopausal, Bazedoxifene, BMD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Instituto PalaciosUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- May 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 18 Mar 2014 (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 aim of this study is see the changes in bone mineral density after discontinuation or stop the use of bisphosphonates and make the switch to bazedoxifene).
Detailed description
The primary hypothesis is: "Comparing to control group (Calcium+VitD), Bazedoxifene group (20mg daily+ calcium+VitD) is efficient in reducing BMD in spine at 12 months of treatment. in postmenopausal women switching from daily, weekly or monthly bisphosphonates therapy. It is a non-inferiority study of Bazedoxifene compared to biphosphonates, being each patient its own control from the baseline. It is a superiority study of Bazedoxifene compared to Calcium+VitD.
Taking into account the difference in the percentage change observed in the total BMD of the spine during 12 months in those patients treated with Bazedoxifene+Ca+VitD at least 110 patients should be included, 55 in each arm of treatment.
This simple size is going to allow us to detect the differences in the percentage change observed in the total BMD of the spine during 12 months between the two treatment arms, being the same or over 0.25%, with a significance level of 95%, an 80% power. It is estimated a standard deviation of 0.5%, and a 10% lost follow-up rate.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bazedoxifene & Calcium/Vit D | Other | Drug: Bazedoxifene, Drug: Calcium/Vit DBazedoxifene 20mg oral once a day and calcium 500mg and 400 IU vitamin D (OSTINE) |
| Calcium/Vit D | Other | Drug: Calcium/Vit DCalcium 500mg and 400 IU vitamin D (OSTINE )daily. |
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ambulatory postmenopausal women 55 years or older at screening
- Have received daily, weekly or monthly oral bisphosphonates at least for 3 years and treatment change is indicated (not responses to bisphosphonates, for bad tolerability or for the potential risk of side effects in a long term treatment with bisphosphonates-indicated by Federal Drug Administration, European Medicines Agency.
- Subjects has stop bisphosphonates therapy no more than one month before screening visit for subjects in daily or weekly bisphosphonates
- Subjects has stop bisphosphonates therapy no more than two months before screening visit for subjects in monthly bisphosphonates
- Screening T-score at the lumbar spine ≤ -2.0 to -4.0 by Dual X ray Absorptiometry (DXA) scan
Key exclusion criteria (11 listed)
- Any disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
- Current use of medication prescribed for osteoporosis other than oral bisphosphonates
- Subjects who had received intravenous bisphosphonates or fluoride (except for dental treatment)
- Subjects who had received any Selective Estrogens Receptor Modulator (SERM), anabolic steroids, systemic hormone replacement, calcitonin or calcitriol within 3 months.
- Subjects who had received strontium ranelate, parathyroid hormone (PTH) or PTH derivates within 1 year.
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 |
|---|---|---|
| BazedoxifeneAlso: Conbriza20 mg Oral daily for 12 months | Drug | Bazedoxifene & Calcium/Vit D |
| Calcium/Vit DAlso: OstineCalcium 500 mg / 400 IU Vit D | Drug | Bazedoxifene & Calcium/Vit D, Calcium/Vit D |
Primary outcome
Lumbar Spine Bone Mineral Density (BMD)
Time frame: 12 months
To evaluate the change in Lumbar Spine Bone Mineral Density (BMD)
4 secondary outcomes
Bone Turnover Markers (BTM´s) carboxy-terminal collagen crosslinks (CTX) and 1 procollagen N-terminal (P1NP)
Time frame: 6 and 12 months from baseline
BMD at the femoral neck
Time frame: 6 and 12 months from baseline
BMD at total hip
Time frame: 6 and 12 months from baseline
Mammography
Time frame: 12 months from baseline
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 Sep 2015.
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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.
Santiago Palacios, MD principal investigator
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bazedoxifene and Calcium/Vit D in people with Osteoporosis, Postmenopausal, run by Instituto Palacios at 3 sites 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 7 inclusion and 11 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 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Lumbar Spine Bone Mineral Density (BMD) (time frame: 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 9 Sep 2015.