Efficacy and Safety of Brand Versus Generic Alendronate for Osteoporosis Treatment

NCT ID: NCT02371252

Last Updated: 2021-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2016-12-31

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.

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.

Conditions

Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

Generic alendronate

Intervention Type: DRUG

The patients will be given the generic alendronate 1 tablet per week for approximately 1 year after enrollment.

Interventions

Generic alendronate

The patients will be given the generic alendronate 1 tablet per week for approximately 1 year after enrollment.

Intervention Type: DRUG

Other Intervention Names

Bonmax

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aasis Unnanuntana, MD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

Siriraj Hospital

Bangkok Noi, Bangkok, Thailand

Countries

Thailand

References

Unnanuntana A, Jarusriwanna A, Songcharoen P. Randomized clinical trial comparing efficacy and safety of brand versus generic alendronate (Bonmax(R)) for osteoporosis treatment. PLoS One. 2017 Jul 5;12(7):e0180325. doi: 10.1371/journal.pone.0180325. eCollection 2017.

Reference Type: DERIVED

PMID: 28678853 (View on PubMed)

Other Identifiers

150/2557(EC3)

Identifier Type: -

Identifier Source: org_study_id