Comparison of the Effect of an Ongoing Treatment With Alendronate or a Drug Holiday on the Fracture Risk in Osteoporotic Patients With Bisphosphonate Long Term Therapy

Condition(s) targeted: Osteoporosis

Intervention: Alendronate (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Evangelisches Krankenhaus Lutherhaus gGmbH

Official(s) and/or principal investigator(s):
Johannes Pfeilschifter, Prof. Dr. med., Study Director, Affiliation: Alfried Krupp Krankenhaus Essen Steele

Overall contact:
Johannes Pfeilschifter, Prof. Dr. med., Phone: +49 (0)201 805, Ext: 1847, Email: johannes.pfeilschifter@krupp-krankenhaus.de

The purpose of this study is to evaluate the efficacy and safety of bisphosphonates in long term treatment of osteoporosis.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Incidence of new osteoporotic fractures

Secondary outcome:

Equivalence of deaths with and without continued bisphosphonate therapy

Incidence of the combination of fractures and deaths

Detailed description: Is a continued treatment with alendronate for another two years after a preceding therapy with bisphosphonates of at least four years able to reduce the incidence of new osteoporotic fractures in patients at high fracture risk compared to a therapy-free interval?

Minimum age: 60 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Postmenopausal women or men > 60 years

- DXA T-Score at lumbar spine, total hip or femur neck <-2,0 before the start of the

bisphosphonate therapy or at baseline or at least one low trauma vertebral fracture grade 2-3 or multiple low trauma vertebral fractures independent of bone mineral densitiy

- Pretreatment with bisphosphonates for at least four years

- Risk for hip and vertebral fractures min. 30% according to DVO-guideline for

osteoporosis 2009

- Signed informed consent

Exclusion Criteria:

- Other pharmacological treatment of osteoporosis during the last 48 months

- Other bone diseases

- Malabsorption syndromes

- Renal insufficiency with a calculated creatinine clearance < 35 ml/min

- Diseases of the esophagus, delayed esophageal clearance

- UUnability to realise the intake instructions

- Hypocalcemia

Johannes Pfeilschifter, Prof. Dr. med., Phone: +49 (0)201 805, Ext: 1847, Email: johannes.pfeilschifter@krupp-krankenhaus.de

Department of Internal Medicine III, Alfried Krupp Krankenhaus Essen Steele, Essen 45276, Germany; Recruiting

Starting date: January 2012
Last updated: March 21, 2012