Safety and efficacy of risedronate in reducing fracture risk in osteoporotic women aged 80 and older: implications for the use of antiresorptive agents in the old and oldest old.
OBJECTIVE
To determine the efficacy of risedronate in reducing vertebral fracture risk in women aged 80 and older with osteoporosis.


METHODS
Pooled analysis of data from three randomized, double-blind, controlled, 3-year-fracture-endpoint trials conducted from November 1993 to April 1998: Hip Intervention Program (HIP), Vertebral Efficacy with Risedronate Therapy-Multinational (VERT-MN), and VERT-North America (NA).


METHODS
Office-based practices, research centers, and osteoporosis clinics in Europe, North America, and Australia.


METHODS
Osteoporotic (femoral neck bone mineral density T-score < -2.5 standard deviations or at least one prevalent vertebral fracture) women aged 80 and older.


METHODS
Patients received placebo (n=688) or risedronate 5 mg/d (n=704) for up to 3 years. All patients received 1,000 mg/d calcium and, if baseline levels were low, up to 500 IU/d vitamin D.


METHODS
Cumulative incidence of new vertebral fractures.


RESULTS
After 1 year, the risk of new vertebral fractures in the risedronate group was 81% lower than with placebo (95% confidence interval=60-91%; P<.001). The number of women who needed to be treated to prevent one new vertebral fracture after 1 year was 12. This early onset of efficacy was consistent across the clinical programs, and antifracture efficacy was confirmed over 3 years. Risedronate was well tolerated, with a safety profile comparable with that of placebo.


CONCLUSIONS
These findings provide the first evidence that, even in the very old, reducing bone resorption rate remains an effective treatment strategy for osteoporosis. Because each therapeutic agent used for the treatment of osteoporosis may have unique characteristics, the observations made in this study should not be assumed to apply to other bisphosphonates.
Boonen
Steven
S
Leuven University Center for Metabolic Bone Diseases and Division of Geriatric Medicine, Katholieke Universiteit Leuven, Herestraat 49, B-3000 Leuven, Belgium.
McClung
Michael R
MR
Eastell
Richard
R
El-Hajj Fuleihan
Ghada
G
Barton
Ian P
IP
Delmas
Pierre
P
D000368:Aged; D000369:Aged, 80 and over; D016723:Bone Remodeling; D002121:Calcium Channel Blockers / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D012968:Etidronic Acid / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D015663:Osteoporosis, Postmenopausal / Q000150:complications / Q000188:drug therapy*; D016016:Proportional Hazards Models; D000068296:Risedronic Acid; D012306:Risk; D016103:Spinal Fractures / Q000209:etiology / Q000517:prevention & control*; D016896:Treatment Outcome
D002121:Calcium Channel Blockers; D000068296:Risedronic Acid; D012968:Etidronic Acid