FOSAMAX SUMMARY
FOSAMAX 1 (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 is indicated for:
- Treatment and prevention of osteoporosis in postmenopausal women
- For the treatment of osteoporosis, FOSAMAX increases bone mass and reduces
the incidence of fractures, including those of the hip and spine (vertebral
compression fractures). Osteoporosis may be confirmed by the finding of low bone
mass (for example, at least 2 standard deviations below the premenopausal mean)
or by the presence or history of osteoporotic fracture. (See CLINICAL PHARMACOLOGY, Pharmacodynamics.)
- For the prevention of osteoporosis, FOSAMAX may be considered in
postmenopausal women who are at risk of developing osteoporosis and for whom the
desired clinical outcome is to maintain bone mass and to reduce the risk of
future fracture.
Bone loss is particularly rapid in postmenopausal women
younger than age 60. Risk factors often associated with the development of
postmenopausal osteoporosis include early menopause; moderately low bone mass
(for example, at least 1 standard deviation below the mean for healthy young
adult women); thin body build; Caucasian or Asian race; and family history of
osteoporosis. The presence of such risk factors may be important when
considering the use of FOSAMAX for prevention of osteoporosis.
Treatment to increase bone mass in men with osteoporosis
Treatment of glucocorticoid-induced osteoporosis in men and women receiving
glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone
and who have low bone mineral density (see PRECAUTIONS,
Glucocorticoid-induced osteoporosis). Patients treated with glucocorticoids
should receive adequate amounts of calcium and vitamin D.
Treatment of Paget's disease of bone in men and women
- Treatment is indicated in patients with Paget's disease of bone having
alkaline phosphatase at least two times the upper limit of normal, or those who
are symptomatic, or those at risk for future complications from their disease.
|
|
NEWS HIGHLIGHTS
Published Studies Related to Fosamax (Alendronate)
A randomized, double blind, placebo-controlled trial of alendronate treatment for
fibrous dysplasia of bone. [2014]
OBJECTIVE: To determine the efficacy of alendronate for treatment of FD... CONCLUSIONS: Alendronate treatment led to a reduction in the bone resorption
Targeted anti-inflammatory systemic therapy for restenosis: The Biorest Liposomal
Alendronate with Stenting sTudy (BLAST)-a double blind, randomized clinical
trial. [2013]
circulating monocyte levels, diabetes mellitus, and acute coronary syndrome... CONCLUSIONS: Intravenous administration of LABR-312 to patients undergoing
Comparing tolerability and efficacy of generic versus brand alendronate: a
randomized clinical study in postmenopausal women with a recent fracture. [2013]
alendronate... CONCLUSIONS: Bone turnover markers were significantly reduced with branded and
Effects of adding alendronate to ongoing hormone therapy on bone mineral density
in postmenopausal Korean women: a randomized, double-blind, placebo-controlled
clinical trial. [2013]
density (BMD) in postmenopausal Korean women... CONCLUSIONS: Compared with HT alone, the addition of ALEN to ongoing HT for 1
Targeted anti-inflammatory systemic therapy for restenosis: the Biorest Liposomal
Alendronate with Stenting sTudy (BLAST)-a double blind, randomized clinical
trial. [2013]
circulating monocyte levels, diabetes mellitus, and acute coronary syndrome... CONCLUSIONS: Intravenous administration of LABR-312 to patients undergoing
Clinical Trials Related to Fosamax (Alendronate)
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
SCI.
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 (Alendronate) Side Effects
Femur Fracture (7166),
Fall (3619),
LOW Turnover Osteopathy (3137),
Osteoarthritis (2671),
Hypertension (2142),
Tooth Disorder (1925),
Anxiety (1869),
Gastrooesophageal Reflux Disease (1770),
Arthralgia (1697),
Depression (1655), more >>
|
PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 20 ratings/reviews, Fosamax has an overall score of 4.40. The effectiveness score is 4.90 and the side effect score is 6.40. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Fosamax review by 63 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | osteoporosis |
| Dosage & duration: | | 70 mg taken once/week for the period of ongoing |
| Other conditions: | | high cholesterol |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | Reduce the osteoporosis |
| Side effects: | | None |
| Comments: | | Take one pill each week, the first thing in t he morning, You must be able to stay up for at least 30 minutes after taking the pill, and you cannot eat or drink anything besides water within 30 minutes of taking a pill, and then you must eat before lying down. |
|
| | Fosamax review by 54 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Moderately Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | Osteopenia in both hips and lower back |
| Dosage & duration: | | 70 mg? iu? per week taken once a week for the period of 7 months |
| Other conditions: | | IBS, Mild depression |
| Other drugs taken: | | Zoloft | | |
Reported Results |
| Benefits: | | Slight increase in bone density in hips, however no change in back (vertabrae) |
| Side effects: | | After taking the drug for 7 months, I literally developed severe gastric reflux one evening (June 2007). Actual acid reflux disappeared within a few days, but symptoms feeling like a hard, sometimes painful lump in my esophagus persisted for months, especially when lying down. Even after giving up Fosamax 2 months after initial symptoms occurred (in Sept '07, the condition persisted. |
| Comments: | | I was sent by my general practitioner for an endoscopy 3 months (Dec '07) after giving up Fosamax, results of which showed irritation of end of esophagus tube where it joins my stomach. I was prescribed Nexium for the condition, and after taking for 3-4 months, the symptoms finally disappeared. I would NEVER take Fosamax or any alendronate based or similar drug again. |
|
| | Fosamax review by 69 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Marginally Effective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | loss of bone density in spine |
| Dosage & duration: | | 70 mg taken weekly for the period of 2 years |
| Other conditions: | | none |
| Other drugs taken: | | simvastatin 20mg daily | | |
Reported Results |
| Benefits: | | bone scan showed no increase bone loss. |
| Side effects: | | mild at first,slight headache,jaw pain,some stiffness in joints.thought that it was drug related,but could tolerate it if it was working.than this spring,started to have increasing pain and swelling ,knees,fingers,trouble lifting up arms.at some point i realized that this was getting serious |
| Comments: | | i stopped taking the medication and i am improving.i have been off medication about 5 weeks now.aspirin only 325 mg 2-3 tabs a day has helped me along with mild frequent exercise |
|
|
|
Page last updated: 2015-08-10
|
