Status:
WITHDRAWN
Bone Healing in Healthy and Post-menopausal Osteoporotic Women
Lead Sponsor:
University College, London
Conditions:
Post-menopausal Osteoporosis
Eligibility:
FEMALE
50+ years
Phase:
NA
Brief Summary
Both the pathogenesis and the treatment of osteoporosis may potentially interfere at different levels on the multi-stage complex cascade of events involved in bone healing/regeneration. To our knowled...
Detailed Description
Despite some contradictory results, there is significant pre-clinical evidence, mainly deriving from fracture studies, of a delay in bone formation together with a decrease in bone mineral density and...
Eligibility Criteria
Inclusion
- Caucasian women, \> 50 years old
- women referring to have reached a menopause status, defined as the permanent cessation of the ovulation, since at least 1 year and presenting a diagnosis of osteoporosis based on dual X-rays energy absorptiometry (DXA) measurement of the bone mineral density at the femur neck or lateral spine (t value 2.5 SD or more below the young female adult mean) (TEST GROUP)
- women in menopausal status since at least 1 year and with normal bone mineral density, as assessed by DXA scan (CONTROL GROUP)
- subjects needing a tooth extraction. The tooth to extract should present at least 30% of its attachment level preserved. Wisdom teeth are excluded from this study
- Subjects must have voluntarily signed the informed consent.
Exclusion
- on hormone replacement therapy (HRT) or taking any other drugs (except Vit D and calcium) for the treatment of osteoporosis (e.g. biphosphonates)
- on chronic treatment (i.e., two weeks or more) with any medication known to affect oral status (e.g., phenytoin, cyclosporine, and non-steroidal anti-inflammatory drugs) within one month from baseline visit.
- affected by systemic diseases recognized to affect bone metabolism (e.g. Cushing's syndrome, Addison's disease, non-controlled diabetes mellitus, leukemia, pernicious anemia, malabsorption syndromes, chronic liver disease, rheumatoid arthritis..)
- on therapy with drugs that can affect bone metabolism (e.g. glucocorticoids, anticonvulsants, anticoagulants, benzodiazepines, cytotoxic drugs, immunosuppressants..)
- affected by any known diseases, infections or recent surgical procedures within 30 days of study initiation.
- knowingly have HIV or Hepatitis
- history of local radiation therapy
- affected by limited mental capacity or language skills such that study information cannot be understood, informed consent cannot be obtained, or simple instructions cannot be followed.
- presented an acute endodontic lesion in the test tooth or in the neighbouring areas to the experimental procedure
- smokers
- suffering from a known psychological disorder
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01826656
Start Date
May 1 2014
End Date
November 1 2015
Last Update
October 27 2017
Active Locations (1)
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1
Eastman Clinical Investigation Centre
London, United Kingdom, WC1X 8LD