Effect of Alendronate 70mg Formulation on Bone Turnover Markers and Patient Reported Outcomes

  • STATUS
    Recruiting
  • End date
    Dec 1, 2022
  • participants needed
    80
  • sponsor
    Labatec Pharma SA
Updated on 26 February 2022
calcium
vitamin d
surgical menopause
fosamax
alendronate
binosto 70mg effervescent tablet

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 treatment adherence (including compliance and persistence).

Details
Condition Osteoporosis, Postmenopausal
Treatment Binosto 70Mg Effervescent Tablet, Fosamax 70Mg Tablet
Clinical Study IdentifierNCT03435094
SponsorLabatec Pharma SA
Last Modified on26 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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