FOSAMAX PLUS D SUMMARY
FOSAMAX PLUS D contains alendronate sodium, a bisphosphonate, and cholecalciferol (vitamin D3).
Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.
FOSAMAX® PLUS D is indicated for:
Treatment of Osteoporosis in Postmenopausal Women
For the treatment of osteoporosis, FOSAMAX PLUS D increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures).
Treatment to Increase Bone Mass in Men with Osteoporosis
Important Limitations of Use
FOSAMAX PLUS D alone should not be used to treat vitamin D deficiency.
The safety and effectiveness of FOSAMAX PLUS D for the treatment of osteoporosis are based on clinical data of four years duration. The optimal duration of use has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis.
Published Studies Related to Fosamax Plus D (Alendronate / Cholecalciferol)
Effect of alendronate and vitamin D on fractional calcium absorption in a double-blind, randomized, placebo-controlled trial in postmenopausal osteoporotic women. [2011.08]
Menopause and increasing age are associated with a decrease in calcium absorption that can contribute to the pathogenesis of osteoporosis. We hypothesized that alendronate plus vitamin D(3) (ALN + D) would increase fractional calcium absorption (FCA)...
Effects of alendronate plus alfacalcidol in osteoporosis patients with a high risk of fracture: the Japanese Osteoporosis Intervention Trial (JOINT) - 02. [2011.06]
CONCLUSIONS: The combination therapy was no more effective for overall vertebral fracture prevention. However, subgroup analysis has shown that it was more effective for fracture prevention in patients with severe vertebral deformity, multiple prevalent vertebral fractures, and for non-vertebral weight-bearing bone fracture prevention.
Randomized trial of alendronate plus vitamin D3 versus standard care in osteoporotic postmenopausal women with vitamin D insufficiency. [2011.06]
Vitamin D insufficiency is common in patients with osteoporosis. We conducted a randomized trial comparing alendronate 70 mg combined with vitamin D(3) 5,600 IU in a single tablet (ALN/D5600, n = 257) with standard care chosen by the patients' personal physicians (n = 258) in patients with postmenopausal osteoporosis (BMD T score </=2.5 or </=1.5 and a prior fragility fracture) who had vitamin D insufficiency (serum 25[OH]D values 8-20 ng/ml) and who were at risk of falls...
Alendronate reduces osteoclast precursors in osteoporosis. [2010.10]
This study evaluates the effect of alendronate on osteoclastogenesis, cytokine production, and bone resorption in postmenopausal women. We suggest that it acts on mature bone resorbing osteoclasts after 3 months of treatment, whereas, after 1 year, it diminishes their formation by reducing their precursors and serum RANKL. INTRODUCTION: Osteoclasts are the target cells of bisphosphonates, though the most drug-sensitive steps of their formation and activity have not been determined. The present study evaluates the effect of alendronate on osteoclastogenesis, cytokine production, and bone resorption in postmenopausal women... CONCLUSIONS: We suggest that alendronate mainly acts on mature bone resorbing osteoclasts in the short term, whereas, its long-term administration diminishes their formation by reducing their precursors and serum RANKL.
Alendronate/vitamin D3 70 mg/2800 IU with and without additional 2800 IU vitamin D3 for osteoporosis: results from the 24-week extension of a 15-week randomized, controlled trial. [2009.04]
Although vitamin D supplementation is a fundamental part of osteoporosis treatment, many patients do not regularly take adequate amounts. A once-weekly (OW) alendronate (ALN) preparation that includes 2800 IU of vitamin D3 in a single combination tablet (ALN+D2800) is available for treating patients and ensuring intake of vitamin D that is consistent with existing guidelines...
Clinical Trials Related to Fosamax Plus D (Alendronate / Cholecalciferol)
FOSAMAX PLUS and FOSAMAX PLUS D Re-examination Study (0217A-267) [Completed]
This survey is conducted for preparing application materials for re-examination under the
Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the
clinical usefulness of FOSAMAX PLUS / FOSAMAX PLUS D through collecting the safety
information according to the Re-examination Regulation for New Drugs.
Note: FOSAMAX PLUS D is known as FOSAMAX PLUS in several markets. FOSAMAX PLUS (70 mg/2800
IU) and FOSAMAX PLUS D (70 mg/5600 IU).
The Effects of Alendronate After Cure of Primary Hyperparathyroidism [Withdrawn]
We are investigating whether, after surgical cure of primary hyperparathyroidism,
alendronate provides even greater beneficial skeletal effects than parathyroidectomy alone.
Primary Hyperparathyroidism (PHPT) is a disorder that can be associated with bone loss.
After successful surgery for PHPT bone density improves without any treatment. However, it
is possible that bone density might improve to an even greater extent if Fosamax is used
after the surgical cure. Fosamax is approved by the FDA for the prevention and treatment of
osteoporosis, and the goal of this project is to determine whether after successful surgical
cure of PHPT, Fosamax is even better for the skeleton than just parathyroid surgery alone.
Pilot Study of Fosamax in Spinal Cord Injury [Terminated]
Study is designed to evaluate the efficacy of oral fosamax in prevention on osteoporosis in
acute spinal cord injury. Efficacy will be measured by a duel energy X-Ray absorptiometry
(DEXA) scan every 6 months. Patients will complete 3 visits, screening, 6 months, 12 months
and be required to take oral fosamax versus placebo weekly.
Bioequivalence Study of Alendronate Sodium Tablets 70 mg of Dr. Reddy's Under Fasting Conditions [Completed]
Effect of Alendronate on Bone in People With Chronic Spinal Cord Injury Previously Treated With Teriparatide [Enrolling by invitation]
The purpose of this study is to determine if a year of alendronate treatment will maintain
or increase bone mass density (BMD) compared to baseline BMD values in people with chronic
This study will also investigate 1) if alendronate therapy will increase bone strength in
people with chronic SCI, 2) the safety of alendronate, and 3) the effects of alendronate on
serum markers of bone metabolism.
Reports of Suspected Fosamax Plus D (Alendronate / Cholecalciferol) Side Effects
Femur Fracture (1268),
LOW Turnover Osteopathy (655),
Tooth Disorder (487),
Pain in Extremity (393),
Gastrooesophageal Reflux Disease (363), more >>
PATIENT REVIEWS / RATINGS / COMMENTS
Based on a total of 1 ratings/reviews, Fosamax Plus D has an overall score of 10. The effectiveness score is 10 and the side effect score is 10. The scores are on ten point scale: 10 - best, 1 - worst.
Fosamax Plus D review by 60 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Highly Effective|
|Side effects:|| || No Side Effects|
|Condition / reason:|| || osteoporosis|
|Dosage & duration:|| || 70mg/2800IU taken 1 weekly for the period of 2 years|
|Other conditions:|| || none|
|Other drugs taken:|| || none|
|Benefits:|| || Between 1998 and 2006, when I was going through menopause, my bone density went from normal to borderline osteoporosis, as shown by the results of two bone density tests given on those dates. After I received my bone density results in 2006, my physician put me on Fosamax, which I have taken regularly for the past two years. When I took a bone density test recently in 2008, my bone mineral density had increased by almost 6% over a two-year period. I remain in the range of osteopenia, but am midway now between normal and osteoporosis in my T-scores. |
|Side effects:|| || I have experienced no adverse side effects at all while taking this medication.|
|Comments:|| || I take a pill in the morning when I get up, once a week, on the same day each week. I take it with an 8 ounce glass of water and do not lay down, eat, or drink anything for at least 30 minutes. I also take calcium/d vitamin supplements daily, eat plenty of dairy products, walk at least 3 times a week, and avoid alcohol and soft drinks. I was already following these dietary habits when my previous bone density tests were done. Because of that, I credit fosamax with the improvement that has taken place. |
Page last updated: 2011-12-09