Denosumab Osteoporosis Trial Results
Amgen (NASDAQ:AMGN) announced full data results from a non-pivotal Phase 3 head-to-head, double-blind trial comparing bone mineral density (BMD) gains in postmenopausal women with low bone mass who transitioned from weekly oral alendronate (Fosamax(R)) to denosumab versus those who continued alendronate therapy.
Additional Data From Separate Head-to-Head Trial Showed More Than 75 Percent of Patients Prefer the Administration and Frequency of Twice-Yearly Subcutaneous Injection Compared to Weekly Oral Pill.
Data presented from the bisphosphonate transition study, also known as the STAND (Study of Transitioning from AleNdronate to Denosumab) trial, demonstrated that subcutaneous injections of denosumab every six months achieved significantly greater increases in BMD versus those achieved with alendronate at all sites measured. For the primary endpoint, denosumab resulted in significant increases in BMD at the total hip compared with alendronate (1.9 percent vs. 1.05 percent, p less than 0.0001). Treatment with denosumab also resulted in significant increases in BMD compared with continued alendronate treatment at all secondary endpoints including the lumbar spine, femoral neck, hip trochanter and 1/3 radius. Top-line results of this trial were previously released in May 2008.
The incidence and types of adverse events observed in the study, including neoplasm and infection, were well-balanced between the denosumab and alendronate treatment groups. The most common adverse events across both treatment arms were back pain, arthralgia, and nasal pharyngitis.
About the 234 Bisphosphonate Transition Study (STAND)
The 234 bisphosphonate transition Phase 3 study was a randomized, double-blind, active controlled, parallel group study. Eligible patients had T-scores of less than -2.0 and greater than -4.0 at the lumbar spine or total hip, and had previously been treated with alendronate. A total of 504 women with low BMD participated in the study, with approximately 250 patients in each arm.
The study's primary endpoint was to evaluate the effect of denosumab treatment (twice-yearly 60 mg) on total hip BMD in women with low bone mass compared to patients continuing alendronate therapy (weekly 70 mg) at 12-months. The secondary endpoints included evaluation of the effects of transitioning to denosumab compared to continuing treatment with alendronate on percent change from baseline in BMD at the lumbar spine, hip trochanter, femoral neck, and 1/3 radius.
About the 141 Head-to-Head Study (DECIDE)
In this Phase 3 double-blind, double-dummy, active controlled study, 1,189 healthy postmenopausal women (T-score less than or equal to -2.0 total hip or spine), were randomized 1:1 to receive either denosumab injection (subcutaneous 60 mg, Q6M) plus placebo tablet (oral weekly), or placebo injection and oral alendronate (70 mg weekly). Patients were followed for one year to assess changes in BMD at the total hip compared to alendronate. Secondary endpoints were to evaluate the effect of denosumab on percent change from baseline in BMD at the lumbar spine, hip trochanter, femoral neck, and 1/3 radius compared to alendronate. Preference and satisfaction were assessed after 12-months of treatment, with patients being asked to complete a 34-item questionnaire to rate their preference and satisfaction with each mode and frequency of administration.
About Denosumab
Denosumab is the first fully human monoclonal antibody in late stage clinical development that specifically targets RANK Ligand, an essential regulator of osteoclasts (the cells that break down bone). Denosumab is being investigated for its potential to inhibit all stages of osteoclast activity through a targeted mechanism. Denosumab is being studied in a range of bone loss conditions including postmenopausal osteoporosis, rheumatoid arthritis, and cancer treatment-induced bone loss (in breast cancer and prostate cancer patients), as well as for its potential to delay bone metastases and inhibit and treat bone destruction across many stages of cancer.
Source: http://www.amgen.com/media/media_pr_detail.jsp?year=2008&releaseID=1197250
Additional Data From Separate Head-to-Head Trial Showed More Than 75 Percent of Patients Prefer the Administration and Frequency of Twice-Yearly Subcutaneous Injection Compared to Weekly Oral Pill.
Data presented from the bisphosphonate transition study, also known as the STAND (Study of Transitioning from AleNdronate to Denosumab) trial, demonstrated that subcutaneous injections of denosumab every six months achieved significantly greater increases in BMD versus those achieved with alendronate at all sites measured. For the primary endpoint, denosumab resulted in significant increases in BMD at the total hip compared with alendronate (1.9 percent vs. 1.05 percent, p less than 0.0001). Treatment with denosumab also resulted in significant increases in BMD compared with continued alendronate treatment at all secondary endpoints including the lumbar spine, femoral neck, hip trochanter and 1/3 radius. Top-line results of this trial were previously released in May 2008.
The incidence and types of adverse events observed in the study, including neoplasm and infection, were well-balanced between the denosumab and alendronate treatment groups. The most common adverse events across both treatment arms were back pain, arthralgia, and nasal pharyngitis.
About the 234 Bisphosphonate Transition Study (STAND)
The 234 bisphosphonate transition Phase 3 study was a randomized, double-blind, active controlled, parallel group study. Eligible patients had T-scores of less than -2.0 and greater than -4.0 at the lumbar spine or total hip, and had previously been treated with alendronate. A total of 504 women with low BMD participated in the study, with approximately 250 patients in each arm.
The study's primary endpoint was to evaluate the effect of denosumab treatment (twice-yearly 60 mg) on total hip BMD in women with low bone mass compared to patients continuing alendronate therapy (weekly 70 mg) at 12-months. The secondary endpoints included evaluation of the effects of transitioning to denosumab compared to continuing treatment with alendronate on percent change from baseline in BMD at the lumbar spine, hip trochanter, femoral neck, and 1/3 radius.
About the 141 Head-to-Head Study (DECIDE)
In this Phase 3 double-blind, double-dummy, active controlled study, 1,189 healthy postmenopausal women (T-score less than or equal to -2.0 total hip or spine), were randomized 1:1 to receive either denosumab injection (subcutaneous 60 mg, Q6M) plus placebo tablet (oral weekly), or placebo injection and oral alendronate (70 mg weekly). Patients were followed for one year to assess changes in BMD at the total hip compared to alendronate. Secondary endpoints were to evaluate the effect of denosumab on percent change from baseline in BMD at the lumbar spine, hip trochanter, femoral neck, and 1/3 radius compared to alendronate. Preference and satisfaction were assessed after 12-months of treatment, with patients being asked to complete a 34-item questionnaire to rate their preference and satisfaction with each mode and frequency of administration.
About Denosumab
Denosumab is the first fully human monoclonal antibody in late stage clinical development that specifically targets RANK Ligand, an essential regulator of osteoclasts (the cells that break down bone). Denosumab is being investigated for its potential to inhibit all stages of osteoclast activity through a targeted mechanism. Denosumab is being studied in a range of bone loss conditions including postmenopausal osteoporosis, rheumatoid arthritis, and cancer treatment-induced bone loss (in breast cancer and prostate cancer patients), as well as for its potential to delay bone metastases and inhibit and treat bone destruction across many stages of cancer.
Source: http://www.amgen.com/media/media_pr_detail.jsp?year=2008&releaseID=1197250
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