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  • . . . Introduction
  • 1. Gastro-Intestinal System
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  • 5. Infections
  • 6. Endocrine System
    • 6.1 Drugs used in diabetes
    • 6.2 Thyroid and antithyroid drugs
    • 6.3 Corticosteroids
    • 6.4 Sex hormones
    • 6.5 Hypothalamic and pituitary hormones and anti-oestrogens
    • 6.6 Drugs affecting bone metabolism
    • 6.7 Other endocrine drugs
  • 7. Obstetrics, Gynaecology and Urinary Tract Disorders
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  • Appendix 1. Drugs for emergency use in General Practice
  • Appendix 2. Palliative Care
  • Appendix 3. Oral Nutritional Supplements (ONS)
  • Appendix 4. Gluten-free and cow's milk protein-free products
  • Medicines No Longer included in the GJF
  • Medicines not recommended for use in NHS Grampian
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6.6 Drugs affecting bone metabolism

Alendronic acid (tablets, once weekly tablets) is used in the treatment and prevention of post-menopausal osteoporosis and low bone mass, and prevention and treatment of corticosteroid induced osteoporosis.

Risedronate sodium (tablets, once weekly tablets) may also be used in the treatment and prevention of osteoporosis, the prevention and treatment of corticosteroid-induced osteoporosis and the treatment of Paget's disease.

Disodium etidronate (tablets) is used in the treatment of Paget's disease prescribed in a single daily dose of 400mg taken at the midpoint of a 4 hour fast.  Treatment should not be for greater than 6 months and it should be prescribed as disodium etidronate.  (Disodium etidronate is also available with calcium carbonate tablets under the proprietary name Didronel PMO® for the treatment of osteoporosis, prevention of bone loss in post-menopausal women, and prevention and treatment of corticosteroid-induced osteoporosis.  Didronel PMO® has been reclassified and is no longer recommended as a treatment choice for new patients.  Didronel PMO® remains on formulary for continuation of prescribing only).

SPECIAL INDICATIONS

Calcitonin (salmon)/salcatonin (synthetic salmon calcitonin injection) is given by intramuscular or subcutaneous injection for the relief of bone pain associated with Paget's disease and neoplastic disease, and for hypercalcaemia.  It is also used in the treatment of post-menopausal osteoporosis.  When used in osteoporosis it should be given in conjunction with calcium and vitamin D supplements.  Calcitonin is less immunogenic than pork calcitonin and is therefore more suitable for long-term therapy.

Denosumab 60mg/mL injection (Prolia®)  is a human monoclonal antibody that inhibits osteoclast formation, function, and survival, thereby decreasing bone resorption. It is given by subcutaneous injection, 60 mg every 6 months for the treatment of osteoporosis in postmenopausal women at increased risk of fractures.  Use is restricted to women with a bone mineral density (BMD) T-score <-2.5 and ≥-4.0 for whom oral bisphosphates are unsuitable due to contraindication, intolerance or inability to comply with the special administration instructions. Treatment may be initiated in the community on the recommendation of a specialist.

Disodium pamidronate (injection) is given by slow intravenous infusion for the treatment of hypercalcaemia of malignancy and osteoporosis.  It is also used for the treatment of Paget's disease.  A typical regime for Paget's disease might involve a total dose of 180mg, either 30mg/week for 6 infusions or 60mg fortnightly (3 infusions).  The rate of infusion should not exceed 60mg/hour.  Adverse effects are usually mild and transient with flu-like symptoms lasting up to 48 hours in some patients.

Ibandronic acid (tablets, concentrate for intravenous infusion)  may be used to treat hypercalcaemia of malignancy, with or without metastases, or to reduce bone damage from bone metastases in breast cancer.

Ibandronic acid 150mg Tablets (Bonviva®)  taken once a month may be used for the treatment of osteoporosis in postmenopausal women in order to reduce the risk of vertebral fractures. 
Ibandronic acid 3mg/3mL injection (Bonviva®)  given every 3 months may be used for the treatment of osteoporosis in postmenopausal women to reduce the risk of vertebral fractures in patients intolerant of oral treatment for osteoporosis . Unlike some other bisphosphonates, efficacy in reducing femoral neck fractures (and other non-vertebral fractures) has not been established. 

Raloxifene (tablets) is reserved for patients in the 55-75 year age band, who are not suitable for HRT and in whom prevention of vertebral fractures alone is considered valuable.  It will usually be considered a second-line therapy with bisphosphonates being first-line treatment for the prevention of all osteoporosis-related fractures and not just vertebral fractures.

Sodium clodronate (capsules) is reserved for the management of osteolytic lesions in multiple myeloma, when injectable disodium pamidronate is unsuitable.

Strontium ranelate (granules for oral suspension)  may be used for the treatment of postmenopausal osteoporosis to reduce the risk of vertebral and hip fractures when bisphosphonates are contra-indicated or not tolerated and then only in women aged over 75 with a previous fracture and T-score < -2.4 or other women at equivalent high risk.  It is available for restricted use under specialist supervision, and may be initiated in the community on the recommendation of a specialist.

Teriparatide (injection)  may be used for the treatment of established (severe) osteoporosis in post-menopausal women (and men see below).  It is given by subcutaneous injection, 20 micrograms daily; max. duration of treatment 18 months (course not to be repeated). It should be restricted to initiation by specialists experienced in the treatment of osteoporosis following assessment of fracture risk including measurement of BMD. Hospital use only
Use for men is restricted to the treatment of established severe osteoporosis in men over 65 years of age who following assessment of fracture risk, according to the FRAX algorithm, have >30% risk of any fracture in the next 10 years, and >25% risk of hip fracture.  .

Zoledronic acid (concentrate for intravenous infusion) may be used for the prevention of skeletal related events in patients with breast cancer and multiple myeloma.  Use is restricted to prescribing by oncologists for patients with breast cancer and multiple myeloma.  It may also be used in the treatment of polyostotic fibrous dysplasia (McCune-Albright syndrome), osteogenesis imperfecta and Engelmann's disease, by a consultant specialising in the management of bone disease [unlicensed indications].
Zoledronic acid 5mg/100mL (solution for infusion Aclasta®)  is used for the treatment of Paget's disease of bone in patients for whom the use of a bisphosphonate is appropriate [ SMC 317/06].
It is also used for the treatment of osteoporosis in post-menopausal women at increased risk of fractures. Use is restricted to patients who are unsuitable for or unable to tolerate oral treatment options for osteoporosis and administered once a year [ SMC 447/08].
Restricted to initiation by a specialist and hospital use only.

Hormone replacement therapy (see 6.4.1) given peri-menopausally will prevent, and can be used to treat, postmenopausal osteoporosis.  It is especially indicated for women with early natural or surgical menopause (before age 45) as they are at high risk of developing osteoporosis.

PRESCRIBING POINTS FOR DRUGS AFFECTING BONE METABOLISM

• Calcium salts (see 9.5.1) may reduce the rate of bone loss in osteoporosis, but are insufficient on their own as therapy for established disease.
• Disodium etidronate and strontium are poorly absorbed and therefore food, particularly calcium-containing products such as milk, should be avoided for at least 2 hours before and after oral treatment.  See SPC/BNF for more details.
• Alendronic acid, and risedronate and ibandronic acid tablets should be swallowed whole with a full glass of water while sitting or standing.  Patients should remain upright after taking dose, check BNF links above for specific counselling points.

GERIATRIC NOTES - DRUGS AFFECTING BONE METABOLISM

To reduce the risk of all sites in frail, elderly (80+) women who have suffered multiple vertebral fractures or had osteoporosis confirmed by DEXA scan should be offered calcium and vitamin D supplementation and be considered for treatment with oral alendronic acid or risedronate.  To minimise side effects once weekly preparations are preferable.  In men with a diagnosis of osteoporosis, to reduce fracture risk at all sites, oral alendronic acid and vitamin D should be offered.