INDICATIONS AND USAGE
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.