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Efficacy and Safety of Brand Versus Generic Alendronate for Osteoporosis Treatment

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ClinicalTrials.gov Identifier: NCT02371252
Recruitment Status : Unknown
Verified September 2016 by Mahidol University.
Recruitment status was:  Recruiting
First Posted : February 25, 2015
Last Update Posted : September 14, 2016
Sponsor:
Information provided by (Responsible Party):
Mahidol University

Brief Summary:

Osteoporosis is a common disease defined as a decrease in bone mass and strength which increases risk of fragility fractures. This disorder may affecting health in many adults which causing disability, morbidity, and mortality. Current first-line medical therapy is bisphosphonates which alendronate is one of the most widely used. However, expenditure on medicines is one of the major problem of inadequate access to treatment.

The investigators hypothesized that generic alendronate will have the same clinical efficacy as the brand formulation. Therefore, the result of this study is extremely crucial. If adequate efficacy of generic alendronate could be established and if it affords the same safety profile as those of brand alendronate, the use of generic alendronate could then be recommended.


Condition or disease Intervention/treatment Phase
Osteoporosis Drug: Generic alendronate Phase 4

Detailed Description:

Osteoporosis is a common disease which estimated that over 200 million people worldwide are suffered. The prevalence is continuing to escalate with the increasingly elderly population. The risk of fragility fractures in elder over age 50 is approximately 50% in women and 20% in men.

Current first-line medical therapy is bisphosphonates which alendronate is one of the most widely used. However, expenditure on medicines is one of the major problem of inadequate access to treatment. Generally, insurances and health care providers prefer physicians to prescribe generic instead of brand drug, due to its lower costs. However, clinical information on bone mineral density (BMD), fracture reduction and side effects with new generic alendronate is limited.

The objective of this study is to evaluate the efficacy and safety of a new generic alendronate (Bonmax®) comparing to brand alendronate (Fosamax®). The efficacy of generic alendronate will be determined by measuring the percent changes of bone mineral densities at lumbar spine and total hip after 1 year of treatment and then comparing to those changes in the brand alendronate group.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Trial Comparing Efficacy and Safety of Brand Versus Generic Alendronate for Osteoporosis Treatment
Study Start Date : April 2014
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Original alendronate (Fosamax)
The patients will be given the brand alendronate (Fosamax®) (70 mg) 1 tablet once a week orally for 1 year after enrollment. In addition, calcium and vitamin D supplementation will be given to all patients.
Active Comparator: Generic alendronate (Bonmax)
The patients will be given the generic alendronate (Bonmax®) (70 mg) 1 tablet once a week orally for 1 year after enrollment. In addition, calcium and vitamin D supplementation will be given to all patients.
Drug: Generic alendronate
The patients will be given the generic alendronate 1 tablet per week for approximately 1 year after enrollment.
Other Name: Bonmax




Primary Outcome Measures :
  1. Bone mineral density (BMD) at lumbar spine (L1-L4) [ Time Frame: 1 year after treatment ]
    Percent changes of bone mineral density at lumbar spine (L1-L4) from baseline to 1-year after treatment will be compared and analysed between 2 groups.


Secondary Outcome Measures :
  1. Bone mineral density (BMD) at femoral neck and total hip [ Time Frame: 1 year after treatment ]
    Percent changes of bone mineral density at femoral neck and total hip from baseline to 1-year after treatment will be compared and analysed between 2 groups.

  2. Bone markers (Beta crosslaps and P1NP) [ Time Frame: 3 months, 6 months, and 1 year after treatment ]
    Percent changes of serum bone markers (Beta crosslaps and P1NP) from baseline to 1-year after treatment will be compared and analysed between 2 groups.

  3. Number of participants with adverse events [ Time Frame: 3 months, 6 months, and 1 year after treatment ]
    Questionaire of safety and side effects after drug consumption including stomachache or reflux, nausea or vomiting, bloating, diarrhea, drug allergy, fatigue, myalgia, arthralgia, fever, dizziness, and hypocalcemia



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: patients who are postmenopausal women or men who aged older than 50 years and meet the indications for osteoporosis treatment according to the Thai Osteoporosis Foundation's 2010 treatment guidelines.

  • History of spinal or hip fractures with low energy trauma.
  • BMD by Dual energy X-ray absorptiometry (DXA) scan with T-score ≤ -2.5 at the femoral neck, total hip, or L1-L4 spine.
  • BMD by DXA scan with T-score between -1 and -2.5 at the femoral neck, total hip, or L1-L4 spine and a 10-year hip fracture probability ≥ 3% or a 10-year major osteoporosis-related fracture probability ≥ 20% based on Fracture risk assessment tool (FRAX)

Exclusion Criteria:

  • Patients who have contraindications to use bisphosphonates e.g. gastroesophageal reflux disease or drug allergy to bisphosphonates
  • Patients with an abnormality of serum calcium levels (more than 10.2 mg/dl or less than 8.7 mg/dl)
  • Patients with estimated glomerular filtration rate less than 30 mL/min/1.73 m2
  • Patients with metabolic bone diseases such as Paget's disease, hyperparathyroidism, etc.
  • Patients who were received anti-osteoporotic drugs during the past 1 year.
  • Patients who currently taking steroids, hormone replacement therapy, or selective estrogen receptor modulators (SERMs) within 1 year.

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): NCT02371252


Contacts
Contact: Aasis Unnanuntana, MD +66-2419-7968 uaasis@gmail.com
Contact: Atthakorn Jarusriwanna, MD +66-2419-7968 wonton2ton@hotmail.com

Locations
Thailand
Siriraj Hospital Recruiting
Bangkok Noi, Bangkok, Thailand, 10700
Contact: Aasis Unnanuntana, MD    +66-2419-7968    uaasis@gmail.com   
Contact: Atthakorn Jarusriwanna, MD    +66-2419-7968    wonton2ton@hotmail.com   
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Aasis Unnanuntana, MD Mahidol University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT02371252     History of Changes
Other Study ID Numbers: 150/2557(EC3)
First Posted: February 25, 2015    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: September 2016

Keywords provided by Mahidol University:
Osteoporosis
Bisphosphonates
Alendronate
Bone mineral density
Bone markers

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs