netFormulary Leicestershire Health Community NHS
Medicines Formulary  
 Search
 Formulary Chapter 6: Endocrine system - Full Chapter
06.06.02  Expand sub section  Bisphosphonates and other drugs affecting bone metabolism
 note 
  • Prescribe for osteoporosis only in line with NICE criteria for primary or secondary prevention
  • All patients at risk of osteoporosis should be offered lifestyle advice i.e. smoking cessation, avoiding excess alcohol, weight-bearing and resisted exercise and adequate intake of calcium and vitamin D.
  • Biphosphonates decrease the risk of vertebral fracture. In addition alendronate and risedronate reduce non vertebral fractures.
  • HRT is no longer considered the first line option for osteoporosis in women over 50 years.
  • Bisphosphonates reduce the rate of bone turnover in Paget's disease and can produce remission for varying lengths of time. They may also help relieve associated bone pain.
  • Calcium and vitamin D (Adcal D3/ Calceos) is recommended for all elderly institutionalised women unless contra-indicated as has been shown to be effective in reducing hip fractures in this group of patients. (Section 9.6.4)
  • All patients who have been receiving corticosteroids at a dose equivalent to 7.5mg/day prednisolone (or more) for 3 months or longer should be assessed. Review dose and duration of treatment. Evidence-based guidelines recommend that men and women over 65 years or with a previous history of fragility fracture should be offered bone protection (bisphosphonates) when starting steroid therapy. In other patients, if steroid therapy is to continue for at least 3 months, then bone densitometry should be considered. A T-score of –1.5 or lower may indicate the need for intervention with a bone sparing agent. Treatment should usually be on specialist advice only.
  • Ibandronic acid is available as a 150mg monthly preparation in treatment of osteoporosis for those where compliance is a significant problem. It may also be used for bone metastases in breast cancer if initiated by an appropriate specialist. For the latter it is given by IV infusion or as an oral preparation at a dose of 50mg daily.
  • Biphosphonates may also be given by IV infusion in treatment of osteoporosis and in Paget’s disease in specific circumstances only. Patient selection criteria.  
  • There have been reports of oespophageal cancer in association with bisphosphonate use. The CSM has concluded that evidence is not strong enough to show that oral bisphosphonates increase risk of oesophageal cancer.  For full information see MHRA link below. 
  • There have also been reports of osteonecrosis of the jaw (ONJ) associated with bisphosphonate use. The risk appears to be higher for those who have had IV bisphosphonate rather than oral ones. (Please see EMEA link below for more information).
  • Raloxifene is also an option for use in line with NICE TA 161.
Alendronic Acid
View adult BNF View SPC online
First Choice
Green
70mg weekly for Osteoporosis. 
Risedronate Sodium
View adult BNF View SPC online
Second Choice
Green
Daily (5mg) or weekly (35mg) for Osteoporosis.
If intolerant or unable to comply with alendronic acid (as per NICE recommendations)
Due to lower incidence of gastric side effects should be used in preference to alendronic acid for those with a history of peptic ulceration.
Also available for treatment of Paget’s disease.
 
Link  MHRA Advice: Bisphosphonates: very rare reports of osteonecrosis of the external auditory canal
   
Alendronic Acid effervescent tablet (Binosto®)
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Green
Osteoporosis treatment only for patients who cannot swallow alendronic acid tablets. Not for use in patients with a feeding tube
 
   
Denosumab (Prolia®)
View adult BNF View SPC online
Restricted Drug Restricted
Amber SCA
Prescribe in line with NICE TA 204 only
 
Link  MHRA Advice: Denosumab (Xgeva®▼, Prolia); intravenous bisphosphonates: osteonecrosis of the jaw-further measures to minimise risk
Link  MHRA Advice: Denosumab 60mg (Prolia▼): rare cases of atypical femoral fracture with long-term use
Link  MHRA Advice: Denosumab: minimising the risk of osteonecrosis of the jaw; monitoring for hypocalcaemia—updated recommendations
Link  NICE TA 204: Denosumab for the prevention of osteoporotic fractures in postmenopausal women
Link  SCA: Denosumab (Prolia®) for post-menopausal osteoporosis
   
Denosumab (Xgeva®)
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Amber SCA
Prescribe in line with NICE TA 265 only

Date of entry of decision to Formulary: January 2013
 
Link  NICE TA 265: Denosumab for the prevention of skeletal-related events in adults with bone metastases from solid tumours
Link  SCA: Denosumab (Xgeva)
Link  MHRA advice: Denosumab (Xgeva▼) for advanced malignancies involving bone: study data show new primary malignancies reported more frequently compared to zoledronate
Link  MHRA advice: Denosumab (Xgeva▼) for giant cell tumour of bone: risk of clinically significant hypercalcaemia following discontinuation
Link  MHRA Advice: Denosumab (Xgeva®▼, Prolia); intravenous bisphosphonates: osteonecrosis of the jaw-further measures to minimise risk
Link  MHRA Advice: Denosumab: minimising the risk of osteonecrosis of the jaw; monitoring for hypocalcaemia—updated recommendations
   
Ibandronic Acid - Oral (ibandronate)
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Amber Simple
Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer as per NICE CG80 
Link  NICE CG 80: Early and locally advanced breast cancer: diagnosis and treatment
   
Teriparatide
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine

For use in women in line with NICE guidance only for 18 months treatment

NHSE commisioned for use in men in line with NHSE commissioning policy 170064P only

 
Link  NICE TA 161: Osteoporosis
   
Zoledronic Acid (Aclasta®)
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Red
 
Link  IV Zoledronic Acid Patient Selection Criteria.
Link  Leicestershire Evaluation: Zoledronic acid in Osteoporosis
   
Raloxifene
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Amber Simple

For secondary prevention of osteoporotic fragility in menopausal women.
For use in line with NICE TA 161

 
Link  NICE TA 161: Raloxifene and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women
   
Ibandronic acid
(50mg tablets)
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Amber Simple

Unlicensed indication
Use in line with NICE ES 15 for prevention of metastases in early breast cancer patients.

 
Link  NICE ES 15: Early breast cancer (preventing recurrence and improving survival): adjuvant bisphosphonates
   
 ....
 Non Formulary Items
Raloxifene

View adult BNF View SPC online Track Changes
Non Formulary
Black

Not recommended by NICE for primary prevention of osteoporotic fragility in menopausal women.

Link  NICE TA160: Raloxifene for the primary prevention of osteoporotic fragility fractures in postmenopausal women
 
Strontium Ranelate

View adult BNF View SPC online Track Changes
Non Formulary
Black

Strontium has been withdrawn by the manufacturer 

Link  MHRA Advice: Strontium ranelate: cardiovascular risk—restricted indication and new monitoring requirements.
 
  
Key
note Notes
Section Title Section Title (top level)
Section Title Section Title (sub level)
First Choice Item First Choice item
Non Formulary Item Non Formulary section
Restricted Drug
Restricted Drug
Unlicensed Drug
Unlicensed
Track Changes
Display tracking information
click to search medicines.org.uk
Link to adult BNF
click to search medicines.org.uk
Link to children's BNF
click to search medicines.org.uk
Link to SPCs
SMC
Scottish Medicines Consortium
High Cost Medicine
High Cost Medicine
Cancer Drugs Fund
Cancer Drugs Fund
NHSE
NHS England
Homecare
Homecare
CCG
CCG

Traffic Light Status Information

Status Description

Black

Drugs not recommended for use in the Leicestershire Health Community because of lack of evidence of clinical effectiveness, cost prioritization or concerns over safety. All new drugs will be black until they have been through the appropriate approval process - then they will appear as a specific entry   

Red

Drugs which should be prescribed only by hospital specialists (clinical review by specialist as appropriate and annually as a minimum).  

Amber SCA

Drugs which would initially be prescribed by a hospital specialist and then by a GP where full agreement to share the care of each specific patient has been reached under a LMSG Shared Care Agreement (SCA). Specific patient monitoring or intervention required.   

Amber Simple

Drugs suitable to be initiated and prescribed in primary care only after specialist assessment and recommendation. A shared care agreement is not required.  

Green Conditional

Drugs for which GPs are able to take full responsibility for prescribing and monitoring subject to specified conditions e.g. prescribing in line with agreed LMSG guidance or able to demonstrate suitable competence see comments under individual entries.   

Green

Drugs for which GPs would normally take full responsibility for prescribing and monitoring. Drugs included in this list have been specifically considered by LMSG.   

netFormulary