6.6. Drugs affecting bone metabolism
6.6.1. Calcitonin and parathyroid hormone
Restrictions: Restricted to specialist use for the treatment of established severe osteoporosis in post-menopausal women for whom parathyroid hormone (PTH 1-84) is not tolerated or appropriate. The treatment of osteoporosis associated with glucocorticoid therapy and the treatment of osteoporosis in men at increased risk of fracture is not recommended by SMC and is non-Formulary.
Restricted to specialist use for the treatment of severe osteoporosis in women with at least two prior vertebral fractures or equivalent high risk according to local prescribing protocol. The use for the treatment of osteoporosis in men is unlicensed and therefore non-Formulary.
Parathyroid hormone injection (Natpar®) for chronic hypoparathyrodism is not recommended for use by SMC and is non-Formulary
6.6.2. Bisphosphonates and other drugs affecting bone metabolism
First line bisphosphonate for osteoporosis. The 70mg once a week standard tablet preparation is the preferred formulation (except in men, where only the daily 10mg preparation is licensed).
For other preparations, see the Total Formulary
Risedronate is the second line bisphosphonate for osteoporosis and should only be used in patients who either fail to tolerate alendronic acid because of gastrointestinal side effects or when alendronic acid is considered inappropriate because of existing active dyspeptic symptoms. Treatment of osteoporosis in men at high risk of fractures remains non-Formulary.
See Prescribing notes for Formulary indications and restrictions on use.
- Osteoporosis: Use in the treatment of osteoporosis in postmenopausal women in restricted to use in those patients for whom oral bisphosphonates are unsuitable, contraindicated or not tolerated in accordance with local protocol. A shared care agreement is in place for this indication and can be accessed here.
- Skeletal-related events: The prevention of skeletal related events in adults with bone metastases from solid tumours is restricted to specialist use in accordance with regional protocol where zoledronic acid is not appropriate (for example, due to renal impairment or venous access problems). Use for this indication remains specialist use only.
- Bone loss in prostate cancer: Use in the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures is not recommended by SMC and remains non-Formulary.
- Osteoporosis in men at increased risk of fractures is not recommended by SMC and remains non-Formulary.
- Giant cell tumour of bone: in adults and skeletally mature adolescents when the condition is unresectable or where surgical resection is likely to result in severe morbidity is not recommended by SMC and remains non-Formulary.
- Prevention of skeletal related events in adults with haematological malignancies involving bone is not recommended by SMC and is non-Formulary.
- Bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture is not recommended by SMC and remains non-Formulary.
SMC advice pertaining to denosumab can be accessed here
NICE Mutiple Technology Appraisals pertaining to denosumab can be accessed here
Near Patient Testing (NPT) arrangements for GPs may be in place for this medicine. See the relevant section in the Prescribing Resources page for current information.
Restrictions: Restricted to patients who are unable to swallow tablets where alendronic acid is the appropriate treatment choice
- Please note that the effervescent formulation is subject to the same administration requirements as the standard tablets.
- The cost differential between the effervescent tablet and the standard tablet formulation is significant. Consider whether alternative non-oral options may be more suitable (may require discussion with specialist service).
Restrictions: Restricted as detailed in the prescribing notes below.
- Prevention of skeletal related events: in adult patient with with solid tumours with symptomatic bone metastases in accordance with regional guidelines.
- Osteoporosis: treatment in post-menopausal women is restricted to specialist use in patients who are unsuitable for or unable to tolerate oral treatment options.
- Paget’s disease: treatment is restricted to specialist use only.
- The treatment of men at inceased risk of fracture, including those with a recent low-trauma hip fracture, is not recommended by SMC.
Restricted to specialist initiation.
- The use of the injection for osteoporosis is restricted to use in patients who are unsuitable for or unable to tolerate oral treatment options for osteoporosis. Treatment initiation should be under specialist supervision.
Skeletal events in cancer patients:
- Restricted to second line use by specialist oncologists for prevention of skeletal events in patients with breast cancer and metastatic bone cancer and to consultants treating tumour induced hypercalcaemia.
Ibandronic acid tablets 150mg remain non-formulary.
Restrictions: Restricted to specialist initiation.
Restricted to specialist use for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture who have experienced a fragility fracture and are at imminent risk of another fragility fracture (within 24 months).