OsteopeniaPhase 3NCT00463268
Osteoporosis Prevention With Low Dose Alendronate
A Phase 3 study testing alendronate and Calcium/Vitamin D in people with Osteopenia, run by University Hospital of Mont-Godinne at 1 site in Belgium.
Trial summary
The purpose of this study is to evaluate the efficacy of the intermittent administration of alendronate in a low dose, 70 mg once every two week, as osteoporosis prevention for menopausal, osteopenic patients, who don't want or can't receive an oestrogenic substitution treatment. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women only
- Conditions the study is for
- Osteopenia
- What is being tested?
- alendronate and Calcium/Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2007to Jan 2012
- 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 45 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 45 to 60 year-old women
- Menopausal since at least 6 months
- Baseline lumbar BMD from -1 till -2.5
Who cannot join
- Bone disease other than osteopenia
- Treatment with selective estrogen receptor modulator (SERMs), calcitonin or hormone replacement therapy within 6 monts prior to randomization
- Former or current treatment with any bisphosphonate or bone forming agents
- Chronic use of oral or iv corticosteroids
- Any diagnosis of malignancy less than 12 months
Trial locations and contacts
1 site in 1 country.
Belgium1 site
University (UCL) Louvain Hospital in Mont-Godinne
Yvoir, Namur, 5530
About this study
Official title: Prevention of Postmenopausal Bone Loss in Osteopenic Women With Alendronate Given on a 70 mg Once-every Two Week Regimen: a 2-year, Double-blind, Placebo-controlled Clinical Trial.
The purpose of this study is to evaluate the efficacy of the intermittent administration of alendronate in a low dose, 70 mg once every two week, as osteoporosis prevention for menopausal, osteopenic patients, who don't want or can't receive an oestrogenic substitution treatment.
- Conditions
- Osteopenia
- Being tested
- alendronate, Calcium/Vitamin D, placebo
- Keywords
- osteopenia, osteoporosis prevention, alendronate
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alendronateDrug
alendronate 70 mg every 2 weeks
Calcium/Vitamin DDietary supplement
Calcium 500 mg and vitamin D supplementation according to serum level
placeboDrug
identical placebo every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Alendronate 70 mg every 2 weeks Receives: Drug: alendronate; Dietary Supplement: Calcium/Vitamin D |
| 2 | Placebo comparator | Alendronate 70 mg placebo tablet every 2 weeks Receives: Dietary Supplement: Calcium/Vitamin D; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of lumbar BMD modification after 2 years
Measured: 2 years
Secondary outcomes (2)
percentage of hip BMD modification (total hip and sub-regions)
Measured: 2 years
percentage of modification of bone remodeling markers
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2007 (estimated)
- Study startSep 2007
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteopeniaStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Mont-Godinne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Boutsen Yves, University Hospital of Mont-Godinne
- Investigators
- Yves R Boutsen, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00463268
- Sponsor's protocol ID
- MG/OP 001
- Status last verified
- May 2013
- First submitted
- 19 Apr 2007
- Last updated
- 29 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Postmenopausal Bone Loss in Osteopenic Women With Alendronate Given on a 70 mg Once-every Two Week Regimen: a 2-year, Double-blind, Placebo-controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT00463268
- Acronym / sponsor ID
- MG/OP 001
- Conditions
- Osteopenia
- Keywords
- osteopenia, osteoporosis prevention, alendronate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University Hospital of Mont-GodinneUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 20 Apr 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.
The purpose of this study is to evaluate the efficacy of the intermittent administration of alendronate in a low dose, 70 mg once every two week, as osteoporosis prevention for menopausal, osteopenic patients, who don't want or can't receive an oestrogenic substitution treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: alendronate, Dietary Supplement: Calcium/Vitamin DAlendronate 70 mg every 2 weeks |
| 2 | Placebo comparator | Dietary Supplement: Calcium/Vitamin D, Drug: placeboAlendronate 70 mg placebo tablet every 2 weeks |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 45 to 60 year-old women
- Menopausal since at least 6 months
- Baseline lumbar BMD from -1 till -2.5
Key exclusion criteria (5 listed)
- Bone disease other than osteopenia
- Treatment with selective estrogen receptor modulator (SERMs), calcitonin or hormone replacement therapy within 6 monts prior to randomization
- Former or current treatment with any bisphosphonate or bone forming agents
- Chronic use of oral or iv corticosteroids
- Any diagnosis of malignancy less than 12 months
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 |
|---|---|---|
| alendronatealendronate 70 mg every 2 weeks | Drug | 1 |
| Calcium/Vitamin DCalcium 500 mg and vitamin D supplementation according to serum level | Dietary supplement | 1, 2 |
| placeboidentical placebo every 2 weeks | Drug | 2 |
Primary outcome
percentage of lumbar BMD modification after 2 years
Time frame: 2 years
2 secondary outcomes
percentage of hip BMD modification (total hip and sub-regions)
Time frame: 2 years
percentage of modification of bone remodeling markers
Time frame: 2 years
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 29 May 2013.
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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.
Yves R Boutsen, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing alendronate and Calcium/Vitamin D in people with Osteopenia, run by University Hospital of Mont-Godinne at 1 site in Belgium.
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 3 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 29 May 2013. 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 Belgium. 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. Some participants in this study may receive a placebo. 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?
percentage of lumbar BMD modification after 2 years (time frame: 2 years). 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 29 May 2013.