Two‐Year Results of Once‐Weekly Administration of Alendronate 70 mg for the Treatment of Postmenopausal Osteoporosis

• Published in: Journal of bone and mineral research Vol. 17; no. 11; pp. 1988 - 1996
• Main Author: Rizzoli, R
• Format: Journal Article
• Language: English
• Published: Washington, DC John Wiley and Sons and The American Society for Bone and Mineral Research (ASBMR) 01.11.2002; American Society for Bone and Mineral Research
• Subjects: Adult; Aged; Aged, 80 and over; alendronate; Alendronate - administration & dosage; Alendronate - adverse effects; Alkaline Phosphatase - blood; Biological and medical sciences; Bone Density - drug effects; bone mass; Bone Resorption; Bones, joints and connective tissue. Antiinflammatory agents; Collagen - urine; Collagen Type I; Double-Blind Method; Drug Administration Schedule; Female; Fractures, Bone - etiology; Gastrointestinal Diseases - chemically induced; Humans; Lumbar Vertebrae - drug effects; Medical sciences; Middle Aged; once‐weekly dosing; osteoporosis; Osteoporosis, Postmenopausal - complications; Osteoporosis, Postmenopausal - drug therapy; Peptides - urine; Pharmacology. Drug treatments; Treatment Outcome; Human; Lumbar spine; Diseases of the osteoarticular system; Single dose; Diphosphonic acid derivatives; Bone disease; Bisphosphonates; Density; Inorganic element; Osteoarticular system; Alendronic acid; Osteoporosis; Bone mass; Treatment; Weekly; Postmenopause; Female
• ISSN: 0884-0431; 1523-4681
• DOI: 10.1359/jbmr.2002.17.11.1988

The aim of this study was to provide confirmation that once‐weekly dosing with 70 mg of alendronate (seven times the daily oral dose) and twice‐weekly dosing with 35 mg is equivalent to the 10‐mg once‐daily regimen and to gain more extensive safety experience with this new dosing regimen. Twelve hundred fifty‐eight postmenopausal women (aged 42–95 years) with osteoporosis (bone mineral density [BMD] of either lumbar spine or femoral neck at least 2.5 SDs below peak young adult mean or prior vertebral or hip fracture) were assigned to receive oral once‐weekly alendronate, 70 mg (n = 519); twice‐weekly alendronate, 35 mg (n = 369); or daily alendronate 10 mg (n = 370) for a total of 2 years of double‐blind experience. Mean BMD increases from baseline (95% CI) at 24 months in the once‐weekly, twice‐weekly, and daily treatment groups, respectively, were 6.8% (6.4, 7.3), 7.0% (6.6, 7.5), and 7.4% (6.9, 7.8) at the lumbar spine and 4.1% (3.8, 4.5), 4.3% (3.9, 4.7), and 4.3% (3.9, 4.7) at the total hip. These increases in BMD as well as the BMD increases at the femoral neck, trochanter, and total body and the reductions of biochemical markers of bone resorption (urinary cross‐linked N‐telopeptides of type I collagen [NTx]) and bone formation (serum bone‐specific alkaline phosphatase [BSAP]) were similar for the three dosing regimens. All treatment regimens were well tolerated with a similar incidence of upper gastrointestinal (GI) adverse experiences. The incidence rates of clinical fractures, captured as adverse experiences, were similar among the groups. The 2‐year results confirm the conclusion reached after 1 year that once‐weekly alendronate is therapeutically equivalent to daily dosing, providing patients with a more convenient dosing option that may potentially enhance adherence to therapy.