Didronel (Etidronate Disodium) - Summary

DIDRONEL SUMMARY

Didronel tablets contain either 200 mg or 400 mg of etidronate disodium, the disodium salt of (1-hydroxyethylidene) diphosphonic acid, for oral administration. This compound, also known as EHDP, regulates bone metabolism.

Didronel is indicated for the treatment of symptomatic Paget's disease of bone and in the prevention and treatment of heterotopic ossification following total hip replacement or due to spinal cord injury. Didronel is not approved for the treatment of osteoporosis.

Paget's Disease:    Didronel is indicated for the treatment of symptomatic Paget's disease of bone. Didronel therapy usually arrests or significantly impedes the disease process as evidenced by:

• Symptomatic relief, including decreased pain and/or increased mobility (experienced by 3 out of 5 patients).
• Reductions in serum alkaline phosphatase and urinary hydroxyproline levels (30% or more in 4 out of 5 patients).
• Histomorphometry showing reduced numbers of osteoclasts and osteoblasts, and more lamellar bone formation.
• Bone scans showing reduced radionuclide uptake at pagetic lesions.

In addition, reductions in pagetically elevated cardiac output and skin temperature have been observed in some patients.

In many patients, the disease process will be suppressed for a period of at least 1 year following cessation of therapy. The upper limit of this period has not been determined.

The effects of the Didronel treatment in patients with asymptomatic Paget's disease have not been studied. However, Didronel treatment of such patients may be warranted if extensive involvement threatens irreversible neurologic damage, major joints, or major weight-bearing bones.

Heterotopic Ossification:    Didronel is indicated in the prevention and treatment of heterotopic ossification following total hip replacement or due to spinal cord injury.

Didronel reduces the incidence of clinically important heterotopic bone by about two-thirds. Among those patients who form heterotopic bone, Didronel retards the progression of immature lesions and reduces the severity by at least half. Follow-up data (at least 9 months posttherapy) suggest these benefits persist.

In total hip replacement patients, Didronel does not promote loosening of the prosthesis or impede trochanteric reattachment.

In spinal cord injury patients, Didronel does not inhibit fracture healing or stabilization of the spine.

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NEWS HIGHLIGHTS

Published Studies Related to Didronel (Etidronate)

Hormone replacement therapy (HRT) or etidronate for osteoporosis in postmenopausal asthmatics on glucocorticoids: a randomised factorial trial. [2009.02]
INTRODUCTION: The study was designed to establish the effects of HRT on osteoporosis and fractures over five years in postmenopausal women with asthma receiving regular glucocorticoids and to compare with etidronate. METHODS: Postmenopausal patients receiving inhaled and/or oral glucocorticoids were randomly assigned to HRT, cyclical etidronate, HRT plus cyclical etidronate or no treatment for five years...

Comparison of the analgesic effects of bisphosphonates: etidronate, alendronate and risedronate by electroalgometry utilizing the fall of skin impedance. [2009]
Analgesic effects of etidronate, alendronate and risedronate were compared in patients with osteoporosis and/or osteoarthritis by measuring the fall of skin impedance along with conventional subjective pain-estimation by visual rating scale (VRS). One hundred ninety-nine postmenopausal women consulting the Osteoporosis and Osteoarthritis Clinic of Katsuragi Hospital complaining of back and/or knee pain were randomly divided into four groups; Group A (49 subjects) given 5 mg/day alendronate, Group E (50 subjects) 200 mg/day etidronate, Group R (50 subjects) 2.5 mg/day risedronate and Group P no bisphosphonate...

Osteoclast inhibitory effects of vitamin K2 alone or in combination with etidronate or risedronate in patients with rheumatoid arthritis: 2-year results. [2008.03]
OBJECTIVE: To investigate the effects of vitamin K2 (Vit K2) alone or in combination with etidronate and risedronate on bone loss, osteoclast induction, and inflammation in patients with rheumatoid arthritis (RA)... CONCLUSION: Vit K2 alone or in combination with bisphosphonates for treatment of osteoporosis in patients with RA may inhibit osteoclast induction via decreases in levels of RANKL.

Longterm effect of intermittent cyclical etidronate therapy on corticosteroid-induced osteoporosis in Japanese patients with connective tissue disease: 7-year followup. [2008.01]
OBJECTIVE: To determine the efficacy and safety of intermittent cyclical etidronate therapy of up to 7 years for corticosteroid-induced osteoporosis... CONCLUSION: Our results indicate that longterm (up to 7 years) intermittent cyclical etidronate therapy is safe and effective for prevention and treatment of corticosteroid-induced osteoporosis in patients with connective tissue diseases.

Etidronate for fracture prevention in amyotrophic lateral sclerosis: A randomized controlled trial. [2006.11]
Incidence of fractures is high in patients with amyotrophic lateral sclerosis (ALS) as compared to age-matched healthy controls. Our previous cross-sectional study showed that immobilization-induced hypercalcemia (i.e., increased bone resorption) and 25-hydroxyvitamin D (25-OHD) deficiency contribute to reduced bone mineral density (BMD)...

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Clinical Trials Related to Didronel (Etidronate)

HRT Versus Etidronate for Osteoporosis and Fractures in Asthmatics Receiving Glucocorticoids. [Completed]
To determine and compare the effects of Hormone replacement therapy (HRT), etidronate, HRT plus etidronate and no treatment over 5 years in the prevention and treatment of glucocorticoid-induced osteoporosis and fractures in post-menopausal women with asthma.

Vitamin K and Bone Turnover in Postmenopausal Women [Completed]
This one year study of the K vitamers phylloquinone (K1) and menatetranone (MK4) will study supplementation effects on bone turnover and bone density. Women at least 5 years postmenopause with normal bone density who do not use estrogen therapy or the following medications may be eligible:

alendronate (Fosamax), risedronate (Actonel), pamidronate (Aredia), etidronate (Didronel), zoledronate (Zometa), teriparatide (Forteo), raloxifene (Evista), tamoxifene, warfarin (Coumadin), anti-seizure medications, prednisone, or oral steroids. Eligible subjects will take calcium and vitamin D (Citracal) twice a day for the first two months and through-out the study. After the first two months, subjects are randomized to the K1, MK4 or placebo groups. Return visits occur at 1, 3, 6 and 12 months. Fasting blood and urine is collected at each visit and bone density is performed at 3 study visits.

Can Alendronate Suppress Calcification and Improve Bone Density in Chronic Peritoneal Dialysis Patients? [Not yet recruiting]
Alendronate is a safe and effective drug for treating osteoporosis in post-menopausal women. However, its safety and efficacy in increasing bone mineral density in chronic peritoneal dialysis (PD) patients have not been investigated. Etidronate, another bisphosphonate, can suppress the extent of coronary artery calcification in chronic hemodialysis patients. The hypothesis of this study is that alendronate can increase bone mineral density and suppress aortic and coronary artery calcification in chronic peritoneal dialysis patients.

SOLID-Effect of Risedronate Sodium at Distal Radius in Colle's Fracture. [Recruiting]
The purpose of this study is to evaluate the efficacy and safety of risedronate sodium (Actonel®) after a wrist fracture in postmenopausal women.

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