Status:
UNKNOWN
Effect of Alendronate 70mg Formulation on Bone Turnover Markers and Patient Reported Outcomes
Lead Sponsor:
Labatec Pharma SA
Conditions:
Osteoporosis, Postmenopausal
Eligibility:
FEMALE
55-90 years
Brief Summary
Compare the data obtained with two formulations of alendronate 70 mg (tablets vs effervescent tablet for buffered solution) on the change in bone turnover markers, on gastric tolerance and on treatmen...
Eligibility Criteria
Inclusion
- Post-menopausal women (at least 5 years after natural / surgical menopause).
- Patients on treatment with alendronate 70mg tablets or alendronate 70mg effervescent tablets for 6-8 months and who will be continued to be treated for a minimum of 12 months.
- Available BTMs (s-CTX), biochemistry (calcium, phosphate, 25-OH vit D, PTH, creatinine) and DXA (lumbar spine, total hip and femoral neck) at the initiation of the treatment.
- Ability to sign an informed patient consent
Exclusion
- Patients who had received a prior osteoporosis treatment with anti-resorptive drugs (bisphosphonate or denosumab) or teriparatide before starting alendronate 70 mg.
- Any secondary cause of osteoporosis including current treatment with glucocorticoids or aromatase inhibitors, inflammatory disorders, malabsorption
- Metabolic or cancer bone disease
- Contra-indications to bisphosphonates according to product labelling
- Known or suspected allergy to study product(s) or related products
- Inability to sign an informed consent
- Previous participation in this study
Key Trial Info
Start Date :
February 25 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03435094
Start Date
February 25 2018
End Date
December 1 2022
Last Update
December 3 2020
Active Locations (2)
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1
Endokrinologische Praxis & Labor
Basel, Canton of Basel-City, Switzerland, 4055
2
Hôpital Universitaire de Genève, Service des maladies osseuses
Geneva, Canton of Geneva, Switzerland, 1211