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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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).

Condition or disease Intervention/treatment
Osteoporosis, Postmenopausal Drug: Binosto 70Mg Effervescent Tablet Drug: Fosamax 70Mg Tablet

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Estimated Study Start Date : February 25, 2018
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03435094


Contacts
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Contact: Aurélie TIREFORD, PharmD +41 22 593 78 54 aurelie.tireford@labatec.ch

Locations
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Switzerland
Endokrinologische Praxis & Labor
Basel, BS, Switzerland, 4055
Contact: Christian Meier, Prof         
Hôpital Universitaire de Genève, Service des maladies osseuses
Genève, GE, Switzerland, 1211
Contact: Serge Ferrari, Prof         
Sponsors and Collaborators
Labatec Pharma SA
Investigators
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Study Director: Aurélie TIREFORD, PharmD Labatec Pharma SA
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Responsible Party: Labatec Pharma SA
ClinicalTrials.gov Identifier: NCT03435094    
Other Study ID Numbers: LAB-BIN-001
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs