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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03435094
Other study ID # LAB-BIN-001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 25, 2018
Est. completion date December 1, 2022

Study information

Verified date December 2020
Source Labatec Pharma SA
Contact Aurélie TIREFORD, PharmD
Phone +41 22 593 78 54
Email aurelie.tireford@labatec.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 1, 2022
Est. primary completion date March 31, 2022
Accepts healthy volunteers No
Gender Female
Age group 55 Years to 90 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Binosto 70Mg Effervescent Tablet
Assess the effect of alendronate 70mg effervescent tablet on bone turnover markers and patient reported outcomes.
Fosamax 70Mg Tablet
Assess the effect of alendronate 70mg tablet on bone turnover markers and patient reported outcomes.

Locations

Country Name City State
Switzerland Endokrinologische Praxis & Labor Basel BS
Switzerland Hôpital Universitaire de Genève, Service des maladies osseuses Genève GE

Sponsors (1)

Lead Sponsor Collaborator
Labatec Pharma SA

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary s-CTX Decrease in the rate of the bone resorption marker s-CTX Change at 6 months, 12 months, 18 months after treatment start
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