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)

Lipid profiles within the SABRE trial of anastrozole with and without risedronate. [2012]
Lipid profiles in women with early breast cancer receiving anastrozole with or without risedronate were examined within an international Phase III/IV study to assess for possible treatment related changes. Postmenopausal women with hormone receptor-positive breast cancer were assigned to 1 of 3 strata by risk of fragility fracture...

Evidence for safety and efficacy of risedronate in men with osteoporosis over 4 years of treatment: Results from the 2-year, open-label, extension study of a 2-year, randomized, double-blind, placebo-controlled study. [2012]
A 2-year, randomized, double-blind, placebo-controlled study in men with osteoporosis demonstrated that treatment with risedronate 35mg once a week significantly decreased bone turnover markers (BTMs) and increased bone mineral density (BMD). This study was extended to include a 2-year, open-label extension to continue to assess the safety and efficacy of risedronate in men with osteoporosis...

Risedronate improves bone mineral density in Crohn's disease: a two year randomized controlled clinical trial. [2012]
density (BMD) in patients with Crohn's disease... CONCLUSIONS: Risedronate, in addition to daily calcium and vitamin D

Efficacy and safety of a novel delayed-release risedronate 35 mg once-a-week tablet. [2012]
risedronate dose before or immediately after breakfast... CONCLUSIONS: Risedronate 35 mg DR weekly is similar in efficacy and safety to

Effects of risedronate and low-dose transdermal testosterone on bone mineral density in women with anorexia nervosa: a randomized, placebo-controlled study. [2011.07]
CONTEXT: Anorexia nervosa is complicated by severe bone loss and clinical fractures. Mechanisms underlying bone loss in adults with anorexia nervosa include increased bone resorption and decreased formation. Estrogen administration has not been shown to prevent bone loss in this population, and to date, there are no approved, effective therapies for this comorbidity. OBJECTIVE: To determine whether antiresorptive therapy with a bisphosphonate alone or in combination with low-dose transdermal testosterone replacement would increase bone mineral density (BMD) in women with anorexia nervosa... CONCLUSIONS: Risedronate administration for 1 yr increased spinal BMD, the primary site of bone loss in women with anorexia nervosa. Low-dose testosterone did not change BMD but increased lean body mass.

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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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Reports of Suspected Actonel (Risedronate) Side Effects

Femur Fracture (584),  Fall (389),  LOW Turnover Osteopathy (258),  Arthralgia (232),  Pain in Extremity (224),  Stress Fracture (184),  Osteoarthritis (174),  Gastrooesophageal Reflux Disease (167),  Osteonecrosis of JAW (166),  Hypertension (159), more >>

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 62 year old female patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		improve bone density
Dosage & duration:		35 mg taken once per week for the period of 2 years
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		There was some leveling out of bone loss.
Side effects:		I started having problems with my right jaw clicking, something similar to TMJ. It went away completely when I stopped taking Actonel. Not sure if it was related, but it seemed odd that it stopped when I quit the drug.
Comments:		Mild osteopenia

Actonel review by 57 year old female patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		osteoporosis
Dosage & duration:		once a week (dosage frequency: 1 month) for the period of same
Other conditions:		Barrette's esophagus
Other drugs taken:		none
		Reported Results
Benefits:		none since could not continue treatment & diagnosis was made from routine, post-menopausal bone-density test (I was not having symptoms).
Side effects:		severe indigestion/heart burn & increasing hoarseness
Comments:		Once a week on same day, take one tablet first thing in a.m. before eating with full glass water and do not lie down or eat anything for 30 mins.