Osteoporosis, PostmenopausalPhase 4NCT00168909
Influence of Alfacalcidol on Falls in Osteopenic/Osteoporotic Postmenopausal Women (ALFA Study)
A Phase 4 study testing alfacalcidol in people with Osteoporosis, Postmenopausal and Osteopenia, run by Charite University, Berlin, Germany at 2 sites in Germany.
Trial summary
The purpose of this study is to evaluate the effect of alfacalcidol 1 µg daily on the number of fallers in postmenopausal, alendronate-treated, osteopenic or osteoporotic women. primary outcome = number of fallers (patients with at least one locomotor fall incl.mixed falls) Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Osteoporosis, Postmenopausal, Osteopenia, Falls
- What is being tested?
- alfacalcidol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 282 participants
- Where
- 2 sitesGermany
- Study dates
- Jun 2003to May 2008
- 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 65 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- age > 65 years
- postmenopausal women
- osteopenia/osteoporosis as defined by WHO criteria
Who cannot join
- Neoplasm or other severe diseases with life expectancy less than one year or expectation of rapid worsening within one year
- Chronic inflammatory rheumatoid disease
- Arthritis with continuous pain and influence on locomotion
- Inflammatory or metabolic bone disease, excluding osteoporosis.
- Subjects with antiosteoporotic medications who are not willing to switch over to alendronate treatment. Estrogen treatment can be continued
- 25-OH-Vitamin D3 < 12 ng/ml (12 ng/ml = 30 mmol/L)
Show all 12Show fewer
- Systemic corticosteroid treatments of more than one month within previous 12 months
- Intolerability for alfacalcidol
- Hypercalcaemia (>2,7 mmol/l)
- Milk alkali syndrome
- Uncorrected, severe visual impairments
- Creatinin > 2.5 mg/dl (>220 µmol/L)
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin
Berlin, 12200
Centre for Muscle and Bone Research, Aerpah-Kliniken Esslingen
Stuttgart, 73732
About this study
Official title: Influence of Alfacalcidol on Falls in Elderly Postmenopausal, Alendronate-Treated, Osteopenic/Osteoporotic Women With High Risk of Falls
The purpose of this study is to evaluate the effect of alfacalcidol 1 µg daily on the number of fallers in postmenopausal, alendronate-treated, osteopenic or osteoporotic women.
primary outcome = number of fallers (patients with at least one locomotor fall incl.mixed falls)
- Conditions
- Osteoporosis, Postmenopausal, Osteopenia, Falls
- Being tested
- alfacalcidol, placebo
- Keywords
- osteoporosis, frailty, falls
- Medical subject headings
- Osteoporosis, Postmenopausal, Bone Diseases, Metabolic, Osteoporosis, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alfacalcidolDrug
alfacalcidol 1 µg once daily, oral, for 3 years
placeboDrug
placebo once daily, oral, for 3 years
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | alfacalcidol 1µg/d Receives: Drug: alfacalcidol |
| 2 | Placebo comparator | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary outcome: number of fallers (patients with at least one locomotor fall incl.mixed falls)
Measured: 3 years
Secondary outcomes (1)
secondary outcome: number of falls (locomotor falls, incl.mixed falls), all falls/fallers, neuromuscular parameters, BMD, biochemical parameters of calcium and bone metabolism; cognition and moods; muscle biopsies
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJun 2003
- Primary completionJul 2007
- Study completionMay 2008
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.
- More trials run by Charite University, Berlin, GermanyThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Investigators
- Dieter Felsenberg, Prof. Dr., Study chair, Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00168909
- Sponsor's protocol ID
- ek.213-07 (IRB)
- Status last verified
- May 2008
- First submitted
- 9 Sep 2005
- Last updated
- 9 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Alfacalcidol on Falls in Elderly Postmenopausal, Alendronate-Treated, Osteopenic/Osteoporotic Women With High Risk of Falls
- ClinicalTrials.gov ID
- NCT00168909
- Acronym / sponsor ID
- ek.213-07 (IRB)
- Conditions
- Osteoporosis, Postmenopausal, Osteopenia, Falls
- Keywords
- osteoporosis, frailty, falls
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jun 2003
- Primary completion
- Jul 2007 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 15 Sep 2005 (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 effect of alfacalcidol 1 µg daily on the number of fallers in postmenopausal, alendronate-treated, osteopenic or osteoporotic women.
primary outcome = number of fallers (patients with at least one locomotor fall incl.mixed falls)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: alfacalcidolalfacalcidol 1µg/d |
| 2 | Placebo comparator | Drug: placeboplacebo |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- age > 65 years
- postmenopausal women
- osteopenia/osteoporosis as defined by WHO criteria
Key exclusion criteria (12 listed)
- Neoplasm or other severe diseases with life expectancy less than one year or expectation of rapid worsening within one year
- Chronic inflammatory rheumatoid disease
- Arthritis with continuous pain and influence on locomotion
- Inflammatory or metabolic bone disease, excluding osteoporosis.
- Subjects with antiosteoporotic medications who are not willing to switch over to alendronate treatment. Estrogen treatment can be continued
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 |
|---|---|---|
| alfacalcidolalfacalcidol 1 µg once daily, oral, for 3 years | Drug | 1 |
| placeboplacebo once daily, oral, for 3 years | Drug | 2 |
Primary outcome
primary outcome: number of fallers (patients with at least one locomotor fall incl.mixed falls)
Time frame: 3 years
1 secondary outcome
secondary outcome: number of falls (locomotor falls, incl.mixed falls), all falls/fallers, neuromuscular parameters, BMD, biochemical parameters of calcium and bone metabolism; cognition and moods; muscle biopsies
Time frame: 3 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 9 May 2008.
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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.
Dieter Felsenberg, Prof. Dr. study chair
Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin, Berlin, Germany
2 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 alfacalcidol in people with Osteoporosis, Postmenopausal and Osteopenia, run by Charite University, Berlin, Germany at 2 sites 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 3 inclusion and 12 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 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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?
primary outcome: number of fallers (patients with at least one locomotor fall incl.mixed falls) (time frame: 3 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 9 May 2008.