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

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ClinicalTrials.gov Identifier: NCT03435094
Recruitment Status : Unknown
Verified February 2018 by Labatec Pharma SA.
Recruitment status was:  Not yet recruiting
First Posted : February 15, 2018
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
Labatec Pharma SA

Tracking Information
First Submitted Date February 1, 2018
First Posted Date February 15, 2018
Last Update Posted Date February 23, 2018
Estimated Study Start Date February 25, 2018
Estimated Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 9, 2018)
s-CTX [ Time Frame: Change at 6 months, 12 months, 18 months after treatment start ]
Decrease in the rate of the bone resorption marker s-CTX
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: February 9, 2018)
  • Gastric tolerance [ Time Frame: Change at 6 months, 12 months, 18 months after treatment start ]
    Gastric tolerance assessed by a questionnaire
  • Adherence (compliance and persistence) [ Time Frame: Change at 6 months, 12 months, 18 months after treatment start ]
    Adherence assessed by a questionnaire
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: February 9, 2018)
Lumbar spine and total hip/femoral neck bone mass density [ Time Frame: Change at 18 months after treatment start ]
Assess BMD change
 
Descriptive Information
Brief Title Effect of Alendronate 70mg Formulation on Bone Turnover Markers and Patient Reported Outcomes
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
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).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Osteoporosis, Postmenopausal
Intervention
  • Drug: Binosto 70Mg Effervescent Tablet
    Assess the effect of alendronate 70mg effervescent tablet on bone turnover markers and patient reported outcomes.
  • Drug: Fosamax 70Mg Tablet
    Assess the effect of alendronate 70mg tablet on bone turnover markers and patient reported outcomes.
Study Groups/Cohorts
  • Fosamax®
    1 group will be treated with alendronate 70 mg tablets (Fosamax®)
    Intervention: Drug: Fosamax 70Mg Tablet
  • Binosto®
    1 group will be treated with alendronate 70 mg effervescent tablets for buffered solution (Binosto®)
    Intervention: Drug: Binosto 70Mg Effervescent Tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: February 9, 2018)
80
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 1, 2019
Estimated Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Female
Ages 55 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT03435094
Other Study ID Numbers LAB-BIN-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Labatec Pharma SA
Study Sponsor Labatec Pharma SA
Collaborators Not Provided
Investigators
Study Director: Aurélie TIREFORD, PharmD Labatec Pharma SA
PRS Account Labatec Pharma SA
Verification Date February 2018