Bisphosphonates and other agents used for tx of Osteoporosis

Corrected calcium / MOA

Corrected calcium= serum calcium + 0.8 (4 - serum albumin)

Bisphosphonates inhibit bone resorption via actions on osteoclasts or on osteoclast precursors which leads to decreases in the rate of bone resorption and an indirect increase in bone mineral density.

alendronate (Fosamax ®):

Dosing (Adults):
Osteoporosis in postmenopausal females: Oral: Prophylaxis: 5 mg once daily or 35 mg once weekly. Treatment: 10 mg once daily or 70 mg once weekly.
Osteoporosis in males: Oral: 10 mg once daily or 70 mg once weekly.

Osteoporosis secondary to glucocorticoids in males and females: Oral: Treatment: 5 mg once daily; a dose of 10 mg once daily should be used in postmenopausal females who are not receiving estrogen.

Paget's disease of bone in males and females: Oral: 40 mg once daily for 6 months.
Retreatment: Relapses during the 12 months following therapy occurred in 9% of patients who responded to treatment. Specific retreatment data are not available. Following a 6-month post-treatment evaluation period, treatment with alendronate may be considered in patients who have relapsed based on increases in serum alkaline phosphatase, which should be measured periodically. Retreatment may also be considered in those who failed to normalize their serum alkaline phosphatase.

Renal Dosing:
CrCl <35 ml/minute: Alendronate is not recommended due to lack of experience.

May cause esophagitis. Alendronate should be taken in the morning with a full glass (eg, 6 to 8 ounces) of plain water at least one-half hour before food, beverages, or other medications.

Supplied:
Oral Solution: 70 mg/75 ml. Tablet: 5 mg, 10 mg, 35 mg, 40 mg, 70 mg.

etidronate (Didronel ®):

Dosing (Adults): Hypercalcemia: 7.5 mg/kg IV over 2 hours once daily x 3 days. Paget's disease: 5-10 mg/kg orally once daily x 6 months or 11-20 mg/kg x 3 months.

ibandronate (Boniva ®):

Bisphosphonate. Dosing (Adults): (usual):
Treatment of postmenopausal osteoporosis: 2.5 mg orally once day or 150 mg once a month.
Prevention of postmenopausal osteoporosis: 2.5 mg orally once daily. 150 mg once a month may be considered.

Supplied: 2.5 mg tablet (once-daily formulation), 150 mg tablet - (once-monthly formulation).

pamidronate (Aredia ®):

Dosing (Adults): Hypercalcemia: 60-90mg IV single dose. Wait at least 7 days before considering retreatment. Usual recommendation for moderate hypercalcemia (corrected serum calcium of 12 to 13.5 milligrams/dL) is 60 to 90 milligrams. The 90 mg dose is recommended for severe hypercalcemia (corrected calcium greater than 13.5 milligrams/dL)

risedronate (Actonel ®):

Dosing (Adults): Paget's disease: 30 mg orally once daily x 2 months. May cause esophagitis. (100 times more potent than pamidronate or alendronate).

Should be taken on an empty stomach in an upright position with at least 6 ounces of plain water. The upright position and empty stomach should be maintained for at least 30 minutes to minimize gastrointestinal adverse events and increase absorption.

[Supplied: 30mg tablet]

tiludronate (Skelid ®):

Dosing (Adults): Paget's disease: 400mg orally once daily x 3 months. Each dose should be taken with 6 to 8 ounces of water. Tiludronate should not be taken within 2 hours of food or other medications.

Zoledronic acid (Zometa®)

Dosing (Adults): (usual): Hypercalcemia of malignancy: 4 mg IV given as a single dose infusion over no less than 15 min; may repeat after a minimum of 7 days if serum calcium does not return to normal or remain normal after initial treatment.
Multiple myeloma/metastatic bone lesions from solid tumors: 4 mg IV infused over 15 min every 3-4 weeks; administer with an oral calcium supplement of 500 mg and a multiple vitamin containing 400 International Units of vitamin D.
Paget's disease: 100-400 mcg as a single infusion infused over 1 hr.

Vigorous saline hydration alone may be sufficient to treat mild, asymptomatic hypercalcemia. The maximum recommended dose of Zometa in hypercalcemia of malignancy (albumin-corrected serum calcium * >/=12 mg/dL [3.0 mmol/L]) is 4 mg. The 4-mg dose must be given as a single-dose intravenous infusion over no less than 15 minutes. Patients should be adequately rehydrated prior to administration of Zometa. Renal function must be carefully monitored in all patients receiving Zometa and possible deterioration in renal function must be assessed prior to retreatment with Zometa.

Osteoporosis - other:

Raloxifene (Evista®)

Dosing (Adults): (usual):
Osteoporosis prevention: 60 mg orally qd.
Osteoporosis treatment: 60 mg orally qd.

INDICATIONS
Treatment and Prevention of Osteoporosis in Postmenopausal Women: EVISTA is indicated for the treatment and prevention of osteoporosis in postmenopausal women.

Reduction in the Risk of Invasive Breast Cancer in Postmenopausal Women with Osteoporosis: EVISTA is indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis.

Reduction in the Risk of Invasive Breast Cancer in Postmenopausal Women at High Risk of Invasive Breast Cancer: EVISTA is indicated for the reduction in risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer. The effect in the reduction in the incidence of breast cancer was shown in a study of postmenopausal women at high risk for breast cancer with a 5-year planned duration with a median follow-up of 4.3 years [see Clinical Studies]. Twenty-seven percent of the participants received drug for 5 years. The long-term effects and the recommended length of treatment are not known.

High risk of breast cancer is defined as at least one breast biopsy showing lobular carcinoma in situ (LCIS) or atypical hyperplasia, one or more first-degree relatives with breast cancer, or a 5-year predicted risk of breast cancer ≥ 1.66% (based on the modified Gail model). Among the factors included in the modified Gail model are the following: current age, number of first-degree relatives with breast cancer, number of breast biopsies, age at menarche, nulliparity or age of first live birth. Healthcare professionals can obtain a Gail Model Risk Assessment Tool by dialing 1-800-545-5979. Currently, no single clinical finding or test result can quantify risk of breast cancer with certainty.

After an assessment of the risk of developing breast cancer, the decision regarding therapy with EVISTA should be based upon an individual assessment of the benefits and risks.

EVISTA does not eliminate the risk of breast cancer. Patients should have breast exams and mammograms before starting EVISTA and should continue regular breast exams and mammograms in keeping with good medical practice after beginning treatment with EVISTA.

Important Limitations of Use for Breast Cancer Risk Reduction

* There are no data available regarding the effect of EVISTA on invasive breast cancer incidence in women with inherited mutations (BRCA1, BRCA2) to be able to make specific recommendations on the effectiveness of EVISTA.
* EVISTA is not indicated for the treatment of invasive breast cancer or reduction of the risk of recurrence.
* EVISTA is not indicated for the reduction in the risk of noninvasive breast cancer.

Dosing (Adults): (usual):
The recommended dosage is one 60 mg EVISTA tablet daily, which may be administered any time of day without regard to meals.

Supplied: 60 mg tablet

Teriparatide (Forteo®)

Dosing (Adults): (usual): Osteoporosis: 20 mcg SC once daily. Administration: give as SC injection into the thigh or abdominal wall. Initial injection should occur where the patient is able to sit or lie down in case symptoms of orthostatic hypertension occur. Use for more than 2 years is not recommended. Teriparatide is the biologically active N-terminal region of the human parathyroid hormone.

Supplied: Solution for injection: 250 mcg/ml (3 ml). Prefilled syringe, delivers teriparatide 20 mcg/dose. Refrigerated.

Disclaimer

Listed dosages are for - Adult patients ONLY. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER. GlobalRPH does not directly or indirectly practice medicine or provide medical services and therefore assumes no liability whatsoever of any kind for the information and data accessed through the Service or for any diagnosis or treatment made in reliance thereon.

David F. McAuley, Pharm.D., R.Ph. GlobalRPh Inc.

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