The tolerability and efficacy of generic alendronate in older women: a randomized trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000329763

Acronym

Nil

Enrollment

197

Registered

2013-03-25

Start date

2013-10-07

Completion date

2014-12-13

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a 3 month prospective randomized 2x2 factorial trial of generic vs proprietary alendronate. 200 participants meeting the admission criteria will be randomly and equally allocated to 4 treatment groups, according to formulation of trial medication (proprietary or generic) and knowledge of formulation (proprietary or generic). Subjects will undergo baseline assessments of medication sensitivity, symptoms, and biochemical markers of bone turnover. Symptom scores will be measured at 2, 6 and 12 weeks. Markers of bone turnover will be measured at 12 weeks. Adherence self-report and tablet counts will be undertaken at the conclusion of the trial.

Interventions

There were 2 randomizations, ie a 2x2 factorial trial: One randomization was to receiving generic alendronate 70mg weekly per oral for 3 months or proprietary alendronate 70mg weekly per oral for 3 months The second randomization was to being informed of taking, either generic alendronate 70mg weekly or proprietary alendronate 70mg weekly per oral for 3 months. Participants were informed verbally by research staff and by labeling on medication container.

Study design

Allocation

Randomised controlled trial

Intervention model

Factorial

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

60 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Female >60y

Exclusion criteria

Medical Conditions - severe renal impairment (eGFR < 30ml/min from review of previous blood tests). - chronic liver disease. - untreated thyroid dysfunction. - current malignancy except for adequately treated BCC, SCC or Cervical CIS. - Paget’s disease of bone. Medications - use of oral glucocorticoid drugs equivalent to an average dose of prednisone 2.5 mg/day in the preceding 12 months - use of oral aminobisphosphonates within the past 3 years, etidronate within the past 1 year, or zoledronate ever - use of estrogen replacement therapy within the last 12 months - use of other medication known to affect bone metabolism

Outcome results