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

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

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).

Study Overview

• Status: Unknown
• Conditions: Osteoporosis, Postmenopausal
• Intervention / Treatment: Drug: Fosamax 70Mg Tablet; Drug: Binosto 70Mg Effervescent Tablet

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Aurélie TIREFORD, PharmD; Phone Number: +41 22 593 78 54; Email: aurelie.tireford@labatec.com

Study Locations

• Switzerland
  • BS
    • Basel, BS, Switzerland, 4055
      • Recruiting
      • Endokrinologische Praxis & Labor
      • Contact: Christian Meier, Prof
  • GE
    • Genève, GE, Switzerland, 1211
      • Recruiting
      • Hôpital Universitaire de Genève, Service des maladies osseuses
      • Contact: Serge Ferrari, Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 53 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Post-menopausal women with osteoporosis, on treatment with Fosamax® or Binosto® for 6-8 months and who will be continued to be treated for a minimum of 12 months, with available BTMs, biochemistry and DXA at the initiation are to be offered participation in the study at the discretion of the treating physician.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Fosamax®; 1 group will be treated with alendronate 70 mg tablets (Fosamax®)	Drug: Fosamax 70Mg Tablet; Assess the effect of alendronate 70mg tablet on bone turnover markers and patient reported outcomes.
Binosto®; 1 group will be treated with alendronate 70 mg effervescent tablets for buffered solution (Binosto®)	Drug: Binosto 70Mg Effervescent Tablet; Assess the effect of alendronate 70mg effervescent tablet on bone turnover markers and patient reported outcomes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
s-CTX	Decrease in the rate of the bone resorption marker s-CTX	Change at 6 months, 12 months, 18 months after treatment start

Collaborators and Investigators

• Sponsor: Labatec Pharma SA
• Investigators: Study Director: Aurélie TIREFORD, PharmD, Labatec Pharma SA

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2018
• Primary Completion (Anticipated): March 31, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: February 1, 2018
• First Submitted That Met QC Criteria: February 9, 2018
• First Posted (Actual): February 15, 2018

Study Record Updates

• Last Update Posted (Actual): December 3, 2020
• Last Update Submitted That Met QC Criteria: December 1, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Osteoporosis, Postmenopausal; Physiological Effects of Drugs; Bone Density Conservation Agents; Alendronate
• Other Study ID Numbers: LAB-BIN-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No