Trial Outcomes & Findings for Efficacy and Safety of Brand Versus Generic Alendronate for Osteoporosis Treatment (NCT NCT02371252)

NCT ID: NCT02371252

Last Updated: 2021-09-29

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 140 participants
• Primary outcome timeframe: 1 year after treatment
• Results posted on: 2021-09-29

Participant Flow

Participant milestones

Measure	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.	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. Generic alendronate: The patients will be given the generic alendronate 1 tablet per week for approximately 1 year after enrollment.
Overall Study STARTED	70	70
Overall Study COMPLETED	70	70
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety of Brand Versus Generic Alendronate for Osteoporosis Treatment

Baseline characteristics by cohort

Measure	Original Alendronate (Fosamax) n=70 Participants 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) n=70 Participants 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. Generic alendronate: The patients will be given the generic alendronate 1 tablet per week for approximately 1 year after enrollment.	Total n=140 Participants Total of all reporting groups
Age, Continuous	73.7 years STANDARD_DEVIATION 9.7 • n=5 Participants	73.7 years STANDARD_DEVIATION 7.2 • n=7 Participants	73.7 years STANDARD_DEVIATION 8.6 • n=5 Participants
Sex: Female, Male Female	66 Participants n=5 Participants	61 Participants n=7 Participants	127 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Original Alendronate (Fosamax) n=70 Participants 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) n=70 Participants 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. Generic alendronate: The patients will be given the generic alendronate 1 tablet per week for approximately 1 year after enrollment.
Bone Mineral Density (BMD) at Lumbar Spine (L1-L4)	5.54 percent Standard Deviation 6.39	5.39 percent Standard Deviation 4.83

SECONDARY outcome

Timeframe: 1 year after treatment

Percent changes of bone mineral density at total hip from baseline to 1-year after treatment will be compared and analysed between 2 groups.

Outcome measures

Measure	Original Alendronate (Fosamax) n=70 Participants 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) n=70 Participants 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. Generic alendronate: The patients will be given the generic alendronate 1 tablet per week for approximately 1 year after enrollment.
Bone Mineral Density (BMD) at Total Hip	2.48 percent Standard Deviation 4.56	2.52 percent Standard Deviation 3.51

SECONDARY outcome

Timeframe: 1 year after treatment

Percent changes of serum bone markers (serum CTX) from baseline to 1-year after treatment will be compared and analysed between 2 groups.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year after treatment

Outcome measures

Outcome data not reported

Adverse Events

Original Alendronate (Fosamax)

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Generic Alendronate (Bonmax)

Serious events: 2 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Original Alendronate (Fosamax) n=70 participants at risk 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) n=70 participants at risk 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.
Musculoskeletal and connective tissue disorders hip fracture	1.4% 1/70 • Number of events 70	2.9% 2/70 • Number of events 70

Other adverse events

Measure	Original Alendronate (Fosamax) n=70 participants at risk 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) n=70 participants at risk 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.
Musculoskeletal and connective tissue disorders myalgia and arthralgia	22.9% 16/70	14.3% 10/70

Additional Information

Dr. Aasis Unnanuntana

Mahidol University

Phone: +66836871159

Email: uaasis@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place