Drugs Affecting Bone Metabolism

Warning

General Notes

Osteoporosis is a condition of low bone mass leading to an increased risk of low trauma fractures. The aim of assessment and treatment is to reduce future fracture risk.

Further information on who to assess, risk factors and pathways for primary/secondary prevention can be found in SIGN 142 Management of osteoporosis and the prevention of fragility fractures.

Formulary options for calcium and vitamin D preparations can be found here.

Osteonecrosis of the jaw

All patients should be informed to maintain good oral hygiene, receive routine dental check-ups, and immediately report any oral symptoms such as dental mobility, pain, or swelling to a doctor and dentist.

Atypical femoral fractures

Patients should be advised to report any new or unusual thigh, hip, or groin pain during treatment with a bisphosphonate or monoclonal antibody.

Calcitonin and Parathyroid Hormone

Specialist use only (S2)

TERIPARATIDE (Movymia®)

  • Movymia® is the preferred brand for new patients who meet the NHS Lanarkshire clinical criteria for teriparatide.
  • Teriparatide (parathyroid hormone 1-34) is restricted to specialist use in patients for the prevention of vertebral and non-vertebral fractures in postmenopausal women with severe osteoporosis.

Bisphosphonates

Preferred list (P)

ALENDRONIC ACID

  • 70mg once a week standard tablet preparation is the preferred formulation. In men, only the daily 10mg preparation is licensed. However, in routine clinical practice the weekly 70 mg preparation is standard. This has become established from bridging studies. See SIGN 142 for further information.
  • Effervescent tablets (Binosto®) were approved by the SMC for the treatment of postmenopausal osteoporosis in those who are unable to swallow tablets, where alendronic acid is the appropriate treatment choice (SMC advice April 2016).

Total list (T)

RISEDRONATE SODIUM

  • Restriction: For patients who suffer minor gastrointestinal intolerance with alendronic acid.

Specialist use only (S2)

ZOLEDRONIC ACID

  • For patients intolerant or unable to comply with the dosing regimen for oral bisphosphonates.
  • Brand Aclasta® is not recommended by the SMC for osteoporosis in men at increased risk of fracture, including those with a recent low-trauma hip fracture.

Prescribing Notes:

  • Patients or carers should be given advice on how to administer oral bisphosphonates:
    • swallow tablets whole with full glass of plain water (not less than 200ml)
    • on rising, take on an empty stomach, at least 30 minutes before first food or drink of the day or, if taking at any other time of the day, avoid food and drink for at least 2 hours before or after (particularly avoid calcium-containing products e.g. milk; also avoid iron and mineral supplements and antacids)
    • stand or sit upright for at least 30 minutes after taking
    • do not take at bedtime or before rising.
  • The need to continue bisphosphonate treatment for osteoporosis should be re-evaluated periodically based on an assessment of the benefits and risks of treatment for individual patients.
  • For patients at high risk of a fragility fracture (>75yrs, previous hip or vertebral fracture or long-term steroids) then treatment should be for 10 years.
  • For lower risk patients then treatment should be re-assessed at 5 years. This could include a repeat DEXA, if the risk of fracture remains high and/or DEXA t-score ≤-2.5 then a total of 10 years of treatment should be considered.
  • IBANDRONIC ACID:

Monoclonal Antibodies

Specialist use only (S2)

DENOSUMAB (Prolia®)

  • For patients intolerant or unable to comply with the dosing regimen for oral bisphosphonates.
  • Subcutaneous denosumab (Prolia®) is an alternative to zoledronic acid for postmenopausal women at increased risk of fractures. Prolia® is not recommended by the SMC for osteoporosis in men at increased risk of fractures
  • Please note: S1 category status arrangements may exist for patients attending non-NHS Lanarkshire specialist services.

ROMOSOZUMAB (Evenity®)

  • Restricted to specialist use for the treatment of postmenopausal women with severe osteoporosis who have previously experienced a fragility fracture, and are at imminent risk (within 24 months) of another fragility fracture.

NHSL Joint Adult Formulary Key

To indicate the category of a formulary medicine, updated sections adopt the following key:

Preferred list (P): First-line formulary choices.

Total list (T): Alternative choices when preferred list options not effective/not tolerated, or not indicated.

Specialist initiation (S1): Specialist initiation, or on the advice of a Consultant or Specialist Practitioner in this therapeutic area. Continuation in primary care is acceptable.

Specialist use only (S2): Supply via hospital, Homecare Service or a hospital based prescription (HBP) for dispensing by community pharmacy. Not prescribed in primary care setting.

Editorial Information

Last reviewed: 31/01/2022

Next review date: 31/01/2025

Author(s): NHSL.

Version: Please refer to the introduction section for an explanation of the review dates above.

Approved By: ADTC

Reviewer name(s): ADTC.