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

Osteoporosis, Postmenopausal Clinical Trial

Official title:

A Non-interventional Two-arm Two-centre, Retrospective/Prospective Study to Compare the Effect of Alendronate 70mg Formulation (Tablet vs Effervescent Tablet) on Bone Turnover Markers and Patient Reported Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03435094
• Other study ID #: LAB-BIN-001
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal

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