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

Labatec

Status

Unknown

Conditions

Osteoporosis, Postmenopausal

Treatments

Drug: Binosto 70Mg Effervescent Tablet

Drug: Fosamax 70Mg Tablet

Study type

Observational

Funder types

Industry

Identifiers

NCT03435094

LAB-BIN-001

Details and patient eligibility

About

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).

Enrollment

80 estimated patients

Sex

Female

Ages

55 to 90 years old

Volunteers

No Healthy Volunteers

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