Efficacy and Safety of Brand Versus Generic Alendronate for Osteoporosis Treatment

NCT02371252 | Completed Phase 4 Results DMC

• 1 other identifier: 150/2557(EC3)
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis

Keywords

Osteoporosis; Bisphosphonates; Alendronate; Bone mineral density; Bone markers

Outcome Measures

Primary Outcomes (1)

• Bone Mineral Density (BMD) at Lumbar Spine (L1-L4)

  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.

  1 year after treatment

Secondary Outcomes (3)

• Bone Mineral Density (BMD) at Total Hip

  1 year after treatment

• Bone Resorption Markers (Serum CTX)

  1 year after treatment

• Bone Formation Marker (Serum PINP)

  1 year after treatment

Study Arms (2)

Original alendronate (Fosamax)

NO INTERVENTION

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.

Generic alendronate (Bonmax)

ACTIVE COMPARATOR

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

Interventions

Generic alendronate DRUG

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

Also known as: Bonmax

Generic alendronate (Bonmax)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Siriraj Hospital

Bangkok Noi, Bangkok, 10700, Thailand

Location

Related Publications (1)

• 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.

  PMID: 28678853 DERIVED

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Limitations and Caveats

small sample sizes and only one generic brand of bisphosphonate was used.

Results Point of Contact

• Title: Dr. Aasis Unnanuntana
• Organization: Mahidol University

uaasis@gmail.com

+66836871159

Study Officials

• Aasis Unnanuntana, MD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2014
• First Posted: February 25, 2015
• Study Start: April 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 29, 2021
• Results First Posted: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)