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The U.K. National Institute for Health and Clinical Excellence said in September that it would recommend the osteoporosis drug denosumab for older women at risk of fractures who cannot take oral bisphosphonates.
NICE's standard treatment recommendation for this patient group is alendronate and either risedronate or etidronate.
All of these agents are oral medications associated with adverse upper-GI effects if not taken according to instructions. Patients must take the medicines before meals and should not lie down for at least half an hour afterward. Denosumab, by contrast, is an injection administered twice annually.
Denosumab (Prolia, Amgen) is a monoclonal antibody that reduces osteoclast activity, limiting bone breakdown.
The NICE reviewers, in deciding to recommend denosumab, considered results from a manufacturer-sponsored phase III randomized controlled trial of denosumab 60 mg subcutaneously every 6 months in 7,868 osteoporotic women aged 60–90 years.
After 3 years, 7.2% of the placebo patients sustained a new vertebral fracture, compared with 2.3% of those who were taking denosumab, a 68% reduction. Nonvertebral fractures were 6.5% with denosumab versus 8% with placebo, and hip fractures were reduced by 40% to 2.3% in the treatment arm.
The drug was also shown to increase bone mineral density at the lumbar spine by 9% over the 3 years compared with placebo, and by 6% at the hip.
The NICE reviewers, while acknowledging denosumab's effectiveness, nonetheless noted that it was not being considered as a replacement for the cheap and widely available oral bisphosphonates, but as an alternative only where these were unsuitable.
Denosumab costs approximately $290.00 for a 1-mL prefilled syringe (60 mg per mL solution), and about $580.00 for 1 year of treatment.
Women eligible for treatment with denosumab must be intolerant of, have contraindications to, or be unable to comply with manufacturer instructions for taking alendronate and risedronate or etidronate.
They must also have bone density scores indicative of fracture risk. Other clinical risk factors for fracture that may be considered are alcohol consumption of more than 4 units per day, parental history of hip fracture, and rheumatoid arthritis.
NICE's guidance on denosumab, which is in final appraisal stage, mirrors its guidance on strontium ranelate, another treatment option for postmenopausal women at risk of fracture who cannot take bisphosphonates.
The U.K. National Institute for Health and Clinical Excellence said in September that it would recommend the osteoporosis drug denosumab for older women at risk of fractures who cannot take oral bisphosphonates.
NICE's standard treatment recommendation for this patient group is alendronate and either risedronate or etidronate.
All of these agents are oral medications associated with adverse upper-GI effects if not taken according to instructions. Patients must take the medicines before meals and should not lie down for at least half an hour afterward. Denosumab, by contrast, is an injection administered twice annually.
Denosumab (Prolia, Amgen) is a monoclonal antibody that reduces osteoclast activity, limiting bone breakdown.
The NICE reviewers, in deciding to recommend denosumab, considered results from a manufacturer-sponsored phase III randomized controlled trial of denosumab 60 mg subcutaneously every 6 months in 7,868 osteoporotic women aged 60–90 years.
After 3 years, 7.2% of the placebo patients sustained a new vertebral fracture, compared with 2.3% of those who were taking denosumab, a 68% reduction. Nonvertebral fractures were 6.5% with denosumab versus 8% with placebo, and hip fractures were reduced by 40% to 2.3% in the treatment arm.
The drug was also shown to increase bone mineral density at the lumbar spine by 9% over the 3 years compared with placebo, and by 6% at the hip.
The NICE reviewers, while acknowledging denosumab's effectiveness, nonetheless noted that it was not being considered as a replacement for the cheap and widely available oral bisphosphonates, but as an alternative only where these were unsuitable.
Denosumab costs approximately $290.00 for a 1-mL prefilled syringe (60 mg per mL solution), and about $580.00 for 1 year of treatment.
Women eligible for treatment with denosumab must be intolerant of, have contraindications to, or be unable to comply with manufacturer instructions for taking alendronate and risedronate or etidronate.
They must also have bone density scores indicative of fracture risk. Other clinical risk factors for fracture that may be considered are alcohol consumption of more than 4 units per day, parental history of hip fracture, and rheumatoid arthritis.
NICE's guidance on denosumab, which is in final appraisal stage, mirrors its guidance on strontium ranelate, another treatment option for postmenopausal women at risk of fracture who cannot take bisphosphonates.
The U.K. National Institute for Health and Clinical Excellence said in September that it would recommend the osteoporosis drug denosumab for older women at risk of fractures who cannot take oral bisphosphonates.
NICE's standard treatment recommendation for this patient group is alendronate and either risedronate or etidronate.
All of these agents are oral medications associated with adverse upper-GI effects if not taken according to instructions. Patients must take the medicines before meals and should not lie down for at least half an hour afterward. Denosumab, by contrast, is an injection administered twice annually.
Denosumab (Prolia, Amgen) is a monoclonal antibody that reduces osteoclast activity, limiting bone breakdown.
The NICE reviewers, in deciding to recommend denosumab, considered results from a manufacturer-sponsored phase III randomized controlled trial of denosumab 60 mg subcutaneously every 6 months in 7,868 osteoporotic women aged 60–90 years.
After 3 years, 7.2% of the placebo patients sustained a new vertebral fracture, compared with 2.3% of those who were taking denosumab, a 68% reduction. Nonvertebral fractures were 6.5% with denosumab versus 8% with placebo, and hip fractures were reduced by 40% to 2.3% in the treatment arm.
The drug was also shown to increase bone mineral density at the lumbar spine by 9% over the 3 years compared with placebo, and by 6% at the hip.
The NICE reviewers, while acknowledging denosumab's effectiveness, nonetheless noted that it was not being considered as a replacement for the cheap and widely available oral bisphosphonates, but as an alternative only where these were unsuitable.
Denosumab costs approximately $290.00 for a 1-mL prefilled syringe (60 mg per mL solution), and about $580.00 for 1 year of treatment.
Women eligible for treatment with denosumab must be intolerant of, have contraindications to, or be unable to comply with manufacturer instructions for taking alendronate and risedronate or etidronate.
They must also have bone density scores indicative of fracture risk. Other clinical risk factors for fracture that may be considered are alcohol consumption of more than 4 units per day, parental history of hip fracture, and rheumatoid arthritis.
NICE's guidance on denosumab, which is in final appraisal stage, mirrors its guidance on strontium ranelate, another treatment option for postmenopausal women at risk of fracture who cannot take bisphosphonates.