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

NCT03435094 | Unknown

• 1 other identifier: LAB-BIN-001
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

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).

Conditions

Osteoporosis, Postmenopausal

Outcome Measures

Primary Outcomes (1)

• s-CTX

  Decrease in the rate of the bone resorption marker s-CTX

  Change at 6 months, 12 months, 18 months after treatment start

Study Arms (2)

Fosamax®

1 group will be treated with alendronate 70 mg tablets (Fosamax®)

Drug: Fosamax 70Mg Tablet

Binosto®

1 group will be treated with alendronate 70 mg effervescent tablets for buffered solution (Binosto®)

Drug: Binosto 70Mg Effervescent Tablet

Interventions

Binosto 70Mg Effervescent Tablet DRUG

Assess the effect of alendronate 70mg effervescent tablet on bone turnover markers and patient reported outcomes.

Binosto®

Fosamax 70Mg Tablet DRUG

Assess the effect of alendronate 70mg tablet on bone turnover markers and patient reported outcomes.

Fosamax®

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Labatec Pharma SA: lead

Study Sites (2)

Endokrinologische Praxis & Labor

Basel, Canton of Basel-City, 4055, Switzerland

RECRUITING

Hôpital Universitaire de Genève, Service des maladies osseuses

Geneva, Canton of Geneva, 1211, Switzerland

RECRUITING

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Alendronate; Tablets

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Aurélie TIREFORD, PharmD

  Labatec Pharma SA

  STUDY DIRECTOR

Central Study Contacts

Aurélie TIREFORD, PharmD

CONTACT

+41 22 593 78 54; aurelie.tireford@labatec.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: February 15, 2018
• Study Start: February 25, 2018
• Primary Completion: March 31, 2022
• Study Completion: December 1, 2022
• Last Updated: December 3, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)