OsteoporosisPhase 3BILANZNCT01512446
Comparison of the Effect of an Ongoing Treatment With Alendronate or a Drug Holiday on the Fracture Risk in Osteoporotic Patients With Bisphosphonate Long Term Therapy
A Phase 3 study testing Alendronate in people with Osteoporosis, run by Evangelisches Krankenhaus Lutherhaus gGmbH at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of bisphosphonates in long term treatment of osteoporosis. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Alendronate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 436 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2012to Mar 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women or men > 60 years
- DXA T-Score at lumbar spine, total hip or femur neck <-2,0 before the start of the bisphosphonate therapy or at baseline or at least one low trauma vertebral fracture grade 2-3 or multiple low trauma vertebral fractures independent of bone mineral densitiy
- Pretreatment with bisphosphonates for at least four years
- Risk for hip and vertebral fractures min. 30% according to DVO-guideline for osteoporosis 2009
- Signed informed consent
Who cannot join
- Other pharmacological treatment of osteoporosis during the last 48 months
- Other bone diseases
- Malabsorption syndromes
- Renal insufficiency with a calculated creatinine clearance < 35 ml/min
- Diseases of the esophagus, delayed esophageal clearance
- UUnability to realise the intake instructions
- Hypocalcemia
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Internal Medicine III, Alfried Krupp Krankenhaus Essen Steele
Essen, 45276
About this study
The purpose of this study is to evaluate the efficacy and safety of bisphosphonates in long term treatment of osteoporosis.
Read the detailed description
Is a continued treatment with alendronate for another two years after a preceding therapy with bisphosphonates of at least four years able to reduce the incidence of new osteoporotic fractures in patients at high fracture risk compared to a therapy-free interval?
- Conditions
- Osteoporosis
- Being tested
- Alendronate, Placebo
- Keywords
- Osteoporosis, Osteoporotic fractures, Bisphosphonate, Pretreatment with bisphosphonates
- Medical subject headings
- Osteoporosis, Osteoporotic Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlendronateDrug
Also called Fosamax
70 mg per week
PlaceboDrug
1 pill per week
| Study group | Role | What they receive |
|---|---|---|
| Alendronate | Active comparator | Not described Receives: Drug: Alendronate |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of New Osteoporotic Fractures
Number of new osteoporotic fractures. All fractures which occurred without high impact trauma (i.e. atraumatically, minor accidents and falls from standing height and lower) were regarded as osteoporotic fractures, except for fractures of fingers, face, skull and toes.
Measured: From baseline to study termination (mean duration 5.6 months)
Secondary outcomes (2)
Mortality
Number of deaths
Measured: From baseline to study termination (mean duration 5.6 months)
Combination of New Osteoporotic Fractures and Deaths
Number of participants with a new osteoporotic fracture or death
Measured: From baseline to study termination (mean duration 5.6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startFeb 2012
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: low recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoporosisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 436 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evangelisches Krankenhaus Lutherhaus gGmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- German Federal Ministry of Education and Research
- Responsible party
- Principal investigator, Prof. Dr. med. Johannes Pfeilschifter, Evangelisches Krankenhaus Lutherhaus gGmbH
- Investigators
- Johannes Pfeilschifter, Prof. Dr. med., Study director, Alfried Krupp Krankenhaus Essen Steele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01512446
- Sponsor's protocol ID
- 2011.1.42
- Other IDs
- 2011-000290-31
- Acronym
- BILANZ
- Status last verified
- Jan 2019
- First submitted
- 11 Jan 2012
- Last updated
- 12 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of an Ongoing Treatment With Alendronate or a Drug Holiday on the Fracture Risk in Osteoporotic Patients With Bisphosphonate Long Term Therapy
- ClinicalTrials.gov ID
- NCT01512446
- Acronym / sponsor ID
- BILANZ / 2011.1.42
- Conditions
- Osteoporosis
- Keywords
- Osteoporosis, Osteoporotic fractures, Bisphosphonate, Pretreatment with bisphosphonates
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low recruitment rate
- Enrolment
- 436 participants (actual)
- Lead sponsor
- Evangelisches Krankenhaus Lutherhaus gGmbHIndustry (pharma, biotech, devices)
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Feb 2012 (actual)
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 19 Jan 2012 (estimated)
- Results
- Posted 17 Jan 2019
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 and safety of bisphosphonates in long term treatment of osteoporosis.
Detailed description
Is a continued treatment with alendronate for another two years after a preceding therapy with bisphosphonates of at least four years able to reduce the incidence of new osteoporotic fractures in patients at high fracture risk compared to a therapy-free interval?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alendronate | Active comparator | Drug: Alendronate |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Postmenopausal women or men > 60 years
- DXA T-Score at lumbar spine, total hip or femur neck <-2,0 before the start of the bisphosphonate therapy or at baseline or at least one low trauma vertebral fracture grade 2-3 or multiple low trauma vertebral fractures independent of bone mineral densitiy
- Pretreatment with bisphosphonates for at least four years
- Risk for hip and vertebral fractures min. 30% according to DVO-guideline for osteoporosis 2009
- Signed informed consent
Key exclusion criteria (7 listed)
- Other pharmacological treatment of osteoporosis during the last 48 months
- Other bone diseases
- Malabsorption syndromes
- Renal insufficiency with a calculated creatinine clearance < 35 ml/min
- Diseases of the esophagus, delayed esophageal clearance
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 |
|---|---|---|
| AlendronateAlso: Fosamax70 mg per week | Drug | Alendronate |
| Placebo1 pill per week | Drug | Placebo |
Primary outcome
Number of New Osteoporotic Fractures
Time frame: From baseline to study termination (mean duration 5.6 months)
Number of new osteoporotic fractures. All fractures which occurred without high impact trauma (i.e. atraumatically, minor accidents and falls from standing height and lower) were regarded as osteoporotic fractures, except for fractures of fingers, face, skull and toes.
2 secondary outcomes
Mortality
Time frame: From baseline to study termination (mean duration 5.6 months)
Combination of New Osteoporotic Fractures and Deaths
Time frame: From baseline to study termination (mean duration 5.6 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Johannes Pfeilschifter, Prof. Dr. med. study director
Alfried Krupp Krankenhaus Essen Steele
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 in people with Osteoporosis, run by Evangelisches Krankenhaus Lutherhaus gGmbH at 1 site in Germany.
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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 12 Feb 2019. 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 Germany. 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?
Yes. Results are posted in the registry (first posted 17 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of New Osteoporotic Fractures (time frame: From baseline to study termination (mean duration 5.6 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 12 Feb 2019.