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

• Conditions: Osteoporosis, Postmenopausal
• Interventions: Drug: Binosto 70Mg Effervescent Tablet; Drug: Fosamax 70Mg Tablet

• Registration Number: NCT03435094
• Lead Sponsor: Labatec Pharma SA

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 treatment adherence (including compliance and persistence).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-01
• Study First Submitted QC: 2018-02-09
• Study First Posted: 2018-02-15
• Study Start: 2018-02-25
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-01
• Last Update Posted: 2020-12-03
• Primary Completion: 2022-03-31
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Binosto®	Binosto 70Mg Effervescent Tablet	1 group will be treated with alendronate 70 mg effervescent tablets for buffered solution (Binosto®)
Fosamax®	Fosamax 70Mg Tablet	1 group will be treated with alendronate 70 mg tablets (Fosamax®)

Primary Outcome Measures

Name	Time	Method
s-CTX	Change at 6 months, 12 months, 18 months after treatment start	Decrease in the rate of the bone resorption marker s-CTX

Trial Locations

Locations (2)

Endokrinologische Praxis & Labor; 🇨🇭 Basel, BS, Switzerland

Hôpital Universitaire de Genève, Service des maladies osseuses; 🇨🇭 Genève, GE, Switzerland