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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03435094

Enrollment

Registered

2018-02-15

Start date

2018-02-25

Completion date

2022-12-01

Last updated

2020-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis, Postmenopausal

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).

Interventions

DRUGBinosto 70Mg Effervescent Tablet

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

DRUGFosamax 70Mg Tablet

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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

55 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Switzerland

Contacts

Primary ContactAurélie TIREFORD, PharmD

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026