Fosamax Plus D (Alendronate Sodium / Cholecalciferol) - Summary

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 D¹ 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.

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NEWS HIGHLIGHTS

Published Studies Related to Fosamax Plus D (Alendronate / Cholecalciferol)

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 trial: comparison of alendronate and alfacalcidol in glucocorticoid-associated osteoporosis in patients with ulcerative colitis. [2009.02.15]
BACKGROUND: Bone loss is often observed in patients with ulcerative colitis, particularly if they require glucocorticoids. AIM: To determine whether the bisphosphonate, alendronate, is safe and effective in preserving bone mass compared to the active vitamin D3, alfacalcidol, in ulcerative colitis patients receiving glucocorticoids... CONCLUSION: Our study indicates that alendronate is a safe, well-tolerated and more effective therapy than alfacalcidol for preventing glucocorticoid-associated bone loss in patients with ulcerative colitis.

Alendronate is effective to treat bone loss in renal transplantation recipients. [2008.12]
Bone loss is a common complication among renal transplant patients. Some studies have shown that alendronate may be effective to treat bone loss in these patients. In this study, we have reported our experience with administration of alendronate to treat bone loss in renal transplanted patients... CONCLUSION: At least in the short term, alendronate is a effective inhibitor for the treatment of bone loss in renal transplantation patients.

A comparison of calcium, calcitriol, and alendronate in corticosteroid-treated premenopausal patients with systemic lupus erythematosus. [2008.12]
OBJECTIVE: To assess bone mineral density (BMD) changes in patients with systemic lupus erythematosus (SLE) undergoing longterm therapy with corticosteroids (CS) while taking calcium, calcitriol, or alendronate. The primary endpoint was BMD changes at 2 years... CONCLUSION: Both calcium alone and calcitriol + calcium preserved lumbar spine BMD in premenopausal patients with SLE taking longterm CS at 2 years, whereas alendronate + calcium led to increases in BMD in lumbar spine and total hip. Premenopausal women taking CS should be considered for osteoporosis prophylaxis.

Alendronate protects premenopausal women from bone loss and fracture associated with high-dose glucocorticoid therapy. [2008.11]
CONCLUSION: Our results indicate that alendronate with alfacalcidol can maintain BMD and protects against high-dose GC-induced bone loss and bone fracture.

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Clinical Trials Related to Fosamax Plus D (Alendronate / Cholecalciferol)

Efficacy and Safety Study of FOSAMAX PLUS D in Postmenopausal Women With Osteoporosis [Recruiting]

The Effects of Alendronate After Cure of Primary Hyperparathyroidism [Recruiting]
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.

Safety and Effectiveness of Oral Alendronate Therapy on Bone Mineral Density in HIV-infected Children and Adolescents With Low Bone Mineral Density [Recruiting]
HIV-infected children, youth, and adults have lower bone mineral density (BMD) than would be expected for HIV-uninfected people of similar age, weight and race. As the majority of perinatally HIV-infected U. S. children are entering or in adolescence, the potential for HIV-related impaired BMD during the adolescent peak of bone mass acquisition is of particular concern. The primary purpose of this study is to compare changes from pre-treatment levels in BMD of the lumbar spine after 24 and 48 weeks of alendronate treatment versus placebo in HIV-infected children and adolescents.

Zoledronic Acid Versus Alendronate for Prevention of Bone Loss After Organ Transplantation [Recruiting]
The purpose of this study is to compare the effectiveness and safety of zoledronic acid with alendronate in the prevention of bone loss after organ transplantation. Zoledronic acid is given as a single intravenous infusion. Alendronate is given as a weekly pill. Both are expected to be very effective, but it is not known which one will work best.

Alendronate for Vascular Calcification in Peritoneal Dialysis Patients? [Not yet recruiting]
Hyperphosphatemia is frequently seen in patients with end-stage renal disease (ESRD). Hyperphosphatemia usually results in a high calcium-phosphorus product (CPP) which may subsequently lead to artery and become a risk factor of cardiovascular complications. Alendronate, due to its effect of inhibiting osteoclasts, is approved for treatment of osteoporosis. Previous reports found the use of bisphosphonates could suppress arterial calcification in hemodialysis dialysis patients. The aim of this study is to evaluate the safety and efficacy of alendronate to suppress coronary artery and aortic calcifications, as well as to improve bone density in chronic peritoneal dialysis (PD) patients.

This study will include ESRD patients who had received maintenance PD for more than 3 months, have high CPP level (≧55), and have chest X-ray proven aortic calcification or coronary artery calcification. All participants are randomly allocated to either group 1 or group 2. Group 1 patients receive alendronate 70 mg once weekly in the first 16 weeks, while group 2 patients receive the same dose of drug every week in the second 16 weeks. The extent of coronary artery and aortic calcification is evaluated by using multi-detector spiral computed tomography, whereas bone mineral density is measured by dual-energy X-ray absorptiometry. Both examinations are performed at week 0, 16 and 32 for each participant. Laboratory studies and possible adverse reactions were regularly monitored.

We expect that alendronate can alleviate the progression of arterial calcification or even improve it. Bone density may also be improved after treatment. Besides, we wish to find the independent factor(s) influencing the efficacy of alendronate. These results may help clinical physicians for early intervention and prevention of cardiovascular complications in ESRD patients.

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PATIENT REVIEWS / RATINGS / COMMENTS

Fosamax Plus D review by 60 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		osteoporosis
Dosage & duration:		70mg/2800IU taken 1 weekly for the period of 2 years
Other conditions:		none
Other drugs taken:		none
		Reported Results
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.