Actonel (Risedronate Sodium) - Summary

ACTONEL SUMMARY

ACTONEL (risedronate sodium tablets) is a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each ACTONEL tablet for oral administration contains the equivalent of 5, 30, or 35 mg of anhydrous risedronate sodium in the form of the hemi-pentahydrate with small amounts of monohydrate.

ACTONEL is indicated for the following:

POSTMENOPAUSAL OSTEOPOROSIS:

ACTONEL is indicated for the treatment and prevention of osteoporosis in postmenopausal women.

TREATMENT OF OSTEOPOROSIS:

In postmenopausal women with osteoporosis, ACTONEL increases BMD and reduces the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures (see CLINICAL STUDIES). Osteoporosis may be confirmed by the presence or history of osteoporotic fracture, or by the finding of low bone mass (for example, at least 2 SD below the premenopausal mean).

PREVENTION OF OSTEOPOROSIS:

ACTONEL 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 fracture.

Factors such as family history of osteoporosis, previous fracture, smoking, BMD (at least 1 SD below the premenopausal mean), high bone turnover, thin body frame, Caucasian or Asian race, and early menopause are associated with an increased risk of developing osteoporosis and fractures. The presence of these risk factors may be important when considering the use of ACTONEL for prevention of osteoporosis.

GLUCOCORTICOID-INDUCED OSTEOPOROSIS:

ACTONEL is indicated for the prevention and treatment of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoid treatment (daily dosage equivalent to 7.5 mg or greater of prednisone) for chronic diseases. Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.

PAGET'S DISEASE:

ACTONEL is indicated for treatment of Paget's disease of bone (osteitis deformans). Treatment is indicated in patients with Paget's disease of bone (1) who have a level of serum alkaline phosphatase at least 2 times the upper limit of normal, or (2) who are symptomatic, or (3) who are at risk for future complications from their disease, to induce remission (normalization of serum alkaline phosphatase).

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NEWS HIGHLIGHTS

Published Studies Related to Actonel (Risedronate)

Risedronate in the treatment of mild pediatric osteogenesis imperfecta: a randomized placebo-controlled study. [2009.07]
Intravenous pamidronate is the most widely used treatment for moderate to severe osteogenesis imperfecta (OI). Currently, there is no medical treatment for patients with mild OI... Future studies should investigate whether oral risedronate is effective in reducing fracture rates in children and adolescents with mild OI type I.

Zoledronic acid and risedronate in the prevention and treatment of glucocorticoid-induced osteoporosis (HORIZON): a multicentre, double-blind, double-dummy, randomised controlled trial. [2009.04.11]
BACKGROUND: Persistent use of glucocorticoid drugs is associated with bone loss and increased fracture risk. Concurrent oral bisphosphonates increase bone mineral density and reduce frequency of vertebral fractures, but are associated with poor compliance and adherence. We aimed to assess whether one intravenous infusion of zoledronic acid was non-inferior to daily oral risedronate for prevention and treatment of glucocorticoid-induced osteoporosis... INTERPRETATION: A single 5 mg intravenous infusion of zoledronic acid is non-inferior, possibly more effective, and more acceptable to patients than is 5 mg of oral risedronate daily for prevention and treatment of bone loss that is associated with glucocorticoid use.

Once-weekly risedronate in men with osteoporosis: results of a 2-year, placebo-controlled, double-blind, multicenter study. [2009.04]
Male osteoporosis is increasingly recognized as a major public health issue. This multinational, 2-yr, randomized, double-blind, placebo-controlled study was conducted to determine the efficacy and safety of 35 mg once-a-week risedronate in men with osteoporosis... The effects of risedronate treatment on BMD and BTMs in this study were similar to those previously shown to be associated with fracture risk reductions in women with postmenopausal osteoporosis.

Phase III randomized, placebo-controlled, double-blind trial of risedronate for the prevention of bone loss in premenopausal women undergoing chemotherapy for primary breast cancer. [2009.03.01]
PURPOSE: Risedronate prevents bone loss in postmenopausal women. The purpose of this study was to determine whether risedronate prevents bone loss in premenopausal women undergoing chemotherapy for breast cancer... CONCLUSION: Risedronate did not prevent bone loss in premenopausal women undergoing adjuvant chemotherapy for breast cancer.

LRP5 Polymorphisms and response to risedronate treatment in osteoporotic men. [2009.03]
Genetic factors are important in the pathogenesis of osteoporosis, but little is known about the genetic determinants of treatment response. Previous studies have shown that polymorphisms of the LRP5 gene are associated with bone mineral density (BMD), but the relationship between LRP5 polymorphisms and response to bisphosphonate treatment in osteoporosis has not been studied...

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Clinical Trials Related to Actonel (Risedronate)

Assess Bioequivalence of One 150 mg Risedronate Tablet Versus Two 75 mg Risedronate Tablets in Healthy Subjects [Completed]
This study is a randomized, open-label, crossover study to assess the bioequivalence of 1 risedronate 150 mg tablet versus 2 risedronate 75 mg tablets administered as a single oral dose. Approximately 320 subjects will be enrolled from 4 study centers in the U. S.

Safety, Pharmacokinetics, and Efficacy of 100, 150, and 200 mg Risedronate Administered to Women With Low BMD [Completed]
A Multi-center, Active-controlled (5 mg daily risedronate), Double-blind, Randomized, Sequential Escalating Dose Study to Assess Safety, Pharmacokinetics and Efficacy of 100, 150, and 200 mg Oral Risedronate Administered Monthly for Six Months in Postmenopausal Women with Low Bone Mineral Density.

Efficacy Study of Risedronate to Prevent Cancer Treatment-Induced Bone Loss in Prostate Cancer [Active, not recruiting]
Prostate cancer patients treated with LHRH agonists (e. g., leuprolide) lose bone mineral density. This is similar to post-menopausal osteoporosis. Risedronate is approved to prevent osteoporosis. We hypothesize that risedronate may also be effective in prostate cancer patients treated with LHRH agonists.

Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children [Active, not recruiting]
Children with Osteogenesis Imperfecta (OI) have bone pain, low bone mass and fractures. There are no approved drugs for the treatment of OI in children, even though some intravenous (IV) bisphosphonates are used off-label in some countries. In a single dose, pharmacokinetic study, data showed that risedronate was well tolerated in 28 children with OI. This three year study will test the safety and efficacy of risedronate in the treatment of children with OI. For the first year, patients will be randomized to the risedronate and placebo groups in a 2: 1 ratio (two groups will receive risedronate, and one group will receive placebo). For the second and third years of the study, all patients will receive risedronate.

Impact of Vertebral Fracture Knowledge on Persistence in Subjects Taking Glucocorticoid Therapy [Completed]
To evaluate the effect of subject knowledge of their disease status on persistence in subjects receiving Actonel 5 mg daily over a 12-month period for the prevention and treatment of GIO.

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PATIENT REVIEWS / RATINGS / COMMENTS

Actonel review by 55 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		post-menopausal osteopenia
Dosage & duration:		35mg taken once a week for the period of Have been taking for 4 years now
Other conditions:		None
Other drugs taken:		None
		Reported Results
Benefits:		My annual bone density scan improved significantly after my first year on Actonel. Although I still have osteopenia, my physician says Actonel is helping to maintain this improvement and it is keep me from progressing to osteoporosis.
Side effects:		I have not had any side effects, not even the heartburn that is the most common one.
Comments:		I take one 35 mg tab of Actonel first thing every Wednesday morning on an empty stomach with a full glass of water, sometimes 2 glasses. I wait at least 30 minutes before I eat or drink anything. While I am supposed to wait at least 30 minutes before lying down again, I confess that on a couple of Wednesday mornings when I was especially tired, I did lay back down. Even then, however, I did not experience any heartburn.

Actonel review by 65 year old female patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		Extremely Severe Side Effects
		Treatment Info
Condition / reason:		prevent osteoporose
Dosage & duration:		25mg taken once a week for the period of 18 months
Other conditions:		rhumatoid arthritis
Other drugs taken:		metothrexate, steroids (5mg / day)
		Reported Results
Benefits:		none: loss of bone density
Side effects:		pain in all bones similar to arthritic pain. Repetitive retinal tears. formation of an epimacular membrane. (after stopping Actonel,the bone pains disappeared within 2 months. No further retinal tears and there is still no need to operate on the epimacular membrane after 2 years)
Comments:		Actonel : 1 pill per week 30 minutes at least before any food / drink intake. Need to stay upright at least 30 minutes.

Actonel review by 65 year old female patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		Extremely Severe Side Effects
		Treatment Info
Condition / reason:		prevent osteoporose
Dosage & duration:		25mg taken once a week for the period of 18 months
Other conditions:		rhumatoid arthritis
Other drugs taken:		metothrexate, steroids (5mg / day)
		Reported Results
Benefits:		none: loss of bone density
Side effects:		pain in all bones similar to arthritic pain. Repetitive retinal tears. formation of an epimacular membrane. (after stopping Actonel,the bone pains disappeared within 2 months. No further retinal tears and there is still no need to operate on the epimacular membrane after 2 years)
Comments:		Actonel : 1 pill per week 30 minutes at least before any food / drink intake. Need to stay upright at least 30 minutes.