OsteoporosisPhase 4OPOZAHNNCT00727493
Osteoporosis and Dental Implant
A Phase 4 study testing alendronate once weekly 70mg in people with Osteoporosis, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate the influence of alendronate therapy on the wound healing after dental implants in patients with osteoporosis. Read more about this study
- Who is it for?
- Ages 60 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- alendronate once weekly 70mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2004to Apr 2010
- 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 60 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal women > 2 years after menopause
- Age between 60 and 75 years
- Possibility to insert a dental implant
- Osteoporosis as defined by WHO criteria (intervention group), or women without osteoporosis / osteopenia (non-intervention group)
Who cannot join
- Pathological findings in the jaw bone
- Chronic inflammatory rheumatoid disease
- Bisphosphonate treatments during the last 12 months
- Inflammatory or metabolic bone disease, excluding osteoporosis
- Systemic corticosteroid treatments of more than one month within previous 12 months
- Severe diseases with life expectancy less than one year or expectation of rapid worsening within one year
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin
Berlin, 12200
Dieter Felsenberg, Prof. Dr., +493084453046
Hendrikje Boerst, Dipl. Wiss. org., +493084454745, hendrikje.boerst@charite.de
About this study
Official title: Evaluation of the Influence of Alendronate on Wound Healing After Dental Implants in Patients With Osteoporosis
The purpose of this study is to evaluate the influence of alendronate therapy on the wound healing after dental implants in patients with osteoporosis.
- Conditions
- Osteoporosis
- Being tested
- alendronate once weekly 70mg, placebo
- Keywords
- osteoporosis,, bisphosphonate, therapy, dental implant
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alendronate once weekly 70mgDrug
alendronate once weekly 70mg, calcium 1000mg and Vitamin D 800 IU daily for 12 months, dental implant
placeboDrug
placebo once weekly; calcium 1000mg and Vitamin D 800 IU daily, dental implant
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | alendronate once weekly 70mg, calcium 1000mg and Vitamin D 800 IU daily, dental implant Receives: Drug: alendronate once weekly 70mg |
| 2 | Placebo comparator | placebo once weekly, calcium 1000mg and Vitamin D 800 IU daily; dental implant Receives: Drug: placebo |
| 3 | No intervention | dental implant, calcium 1000mg and Vitamin D 800 IU daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental CT
Measured: baseline, and 3,6,12 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2008 (estimated)
- Study startJan 2004
- Primary completionJan 2010 (estimated)
- Study completionApr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Investigators
- Dieter Felsenberg, Prof. D.r, Study chair, Leader of the center for muscle and bone research, Charité
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00727493
- Sponsor's protocol ID
- OPOZAHN
- Acronym
- OPOZAHN
- Status last verified
- Aug 2008
- First submitted
- 31 Jul 2008
- Last updated
- 4 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Influence of Alendronate on Wound Healing After Dental Implants in Patients With Osteoporosis
- ClinicalTrials.gov ID
- NCT00727493
- Acronym / sponsor ID
- OPOZAHN / OPOZAHN
- Conditions
- Osteoporosis
- Keywords
- osteoporosis,, bisphosphonate, therapy, dental implant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Jan 2010 (estimated)
- Study completion
- Apr 2010 (estimated)
- First posted
- 4 Aug 2008 (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 influence of alendronate therapy on the wound healing after dental implants in patients with osteoporosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: alendronate once weekly 70mgalendronate once weekly 70mg, calcium 1000mg and Vitamin D 800 IU daily, dental implant |
| 2 | Placebo comparator | Drug: placeboplacebo once weekly, calcium 1000mg and Vitamin D 800 IU daily; dental implant |
| 3 | No intervention | –dental implant, calcium 1000mg and Vitamin D 800 IU daily |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Postmenopausal women > 2 years after menopause
- Age between 60 and 75 years
- Possibility to insert a dental implant
- Osteoporosis as defined by WHO criteria (intervention group), or women without osteoporosis / osteopenia (non-intervention group)
Key exclusion criteria (6 listed)
- Pathological findings in the jaw bone
- Chronic inflammatory rheumatoid disease
- Bisphosphonate treatments during the last 12 months
- Inflammatory or metabolic bone disease, excluding osteoporosis
- Systemic corticosteroid treatments of more than one month within previous 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 |
|---|---|---|
| alendronate once weekly 70mgalendronate once weekly 70mg, calcium 1000mg and Vitamin D 800 IU daily for 12 months, dental implant | Drug | 1 |
| placeboplacebo once weekly; calcium 1000mg and Vitamin D 800 IU daily, dental implant | Drug | 2 |
Primary outcome
Dental CT
Time frame: baseline, and 3,6,12 months after baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 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. D.r study chair
Leader of the center for muscle and bone research, Charité
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 alendronate once weekly 70mg in people with Osteoporosis, run by Charite University, Berlin, Germany 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 4 Aug 2008. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dieter Felsenberg, Prof. Dr. (+490384453046, dieter.felsenberg@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental CT (time frame: baseline, and 3,6,12 months after baseline). 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 4 Aug 2008.