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Status unknownNCT00727493OPOZAHNUpdated Aug 4, 2008

Osteoporosis and Dental Implant

A Phase 4 interventional study of alendronate once weekly 70mg and placebo in Osteoporosis, sponsored by Charite University, Berlin, Germany. Status unknown at 1 site in Germany. Open to female participants aged 60 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-08-04.

Sponsored by Charite University, Berlin, Germany · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2008), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
60 Years to 75 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Osteoporosis

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Keywords

  • osteoporosis,
  • bisphosphonate
  • therapy
  • dental implant
03

In context

Osteoporosis

1,675 studies on the registry are indexed under Osteoporosis; 211 are open to participants now.

This study's planned enrollment of 45 is below the median of 95 across 1,152 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 854 studies on the registry; 127 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
45 participants (estimated)

Study arms

  • Active comparator
    1

    alendronate once weekly 70mg, calcium 1000mg and Vitamin D 800 IU daily, dental implant

    Drug: alendronate once weekly 70mg

  • Placebo comparator
    2

    placebo once weekly, calcium 1000mg and Vitamin D 800 IU daily; dental implant

    Drug: placebo

  • No intervention
    3

    dental implant, calcium 1000mg and Vitamin D 800 IU daily

Interventions

  • Drugalendronate once weekly 70mg

    alendronate once weekly 70mg, calcium 1000mg and Vitamin D 800 IU daily for 12 months, dental implant

  • Drugplacebo

    placebo once weekly; calcium 1000mg and Vitamin D 800 IU daily, dental implant

06

What researchers measure

Primary outcomes

  1. Dental CT

    Time frame: baseline, and 3,6,12 months after baseline

07

Study locations

1 of 1 sites recruiting
  • Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin
    Berlin, 12200, Germany
    • Dieter Felsenberg, Prof. Dr. · Contact · +493084453046
    • Hendrikje Boerst, Dipl. Wiss. org. · Contact · hendrikje.boerst@charite.de · +493084454745
    • Dieter Felsenberg, Prof. Dr. · Principal investigator
    • Anton ° Friedman, Dr. · Sub investigator
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2004, a primary completion of Jan 2010 and a completion of Apr 2010. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 31, 2008
First posted
Aug 4, 2008
Start
Jan 2004
Primary completionEst.
Jan 2010
CompletionEst.
Apr 2010
Last update
Aug 4, 2008
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 4, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00727493
Lead sponsor
Charite University, Berlin, Germany
First posted
Aug 4, 2008
Start date
Jan 2004
Primary completion
Jan 2010 (estimated)
Completion
Apr 2010 (estimated)
Last update
Aug 4, 2008

Study contacts

Dieter Felsenberg, Prof. Dr.
Contact
dieter.felsenberg@charite.de
+490384453046
Hendrikje Boerst, Dipl. Wiss org.
Contact
hendrikje.boerst@charite.de
+490384454745
Dieter Felsenberg, Prof. D.r
study chair · Leader of the center for muscle and bone research, Charité

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2008. You cannot join it, but the record below documents what was studied.

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Discussion

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