Osteoporosis
SIGN 142: Osteoporosis NICE CG146: Osteoporosis NICE TA160: Raloxifene and teriparatide NICE TA161: Raloxifene
Prescribing Notes:
- The aim of treatment is the prevention of fracture.
- Treatment is indicated in patients with a high risk of fracture and osteoporosis as assessed by dual energy x-ray absorptiometry (DEXA) scanning.
- Fracture risk assessment should be undertaken with QFracture or FRAX prior to DEXA referral; DEXA should be considered in patients with a 10-year fracture risk of 10% or greater.
- Before starting treatment, calcium, phosphate, alkaline phosphatase and renal function should be checked.
- Those with, or at risk of, osteoporosis should maintain an adequate intake of calcium and vitamin D. If deficiency is suspected, this should be corrected by increasing dietary intake or taking supplements. An on-line dietary calcium calculator is available at the rheumatology and bone disease website at Edinburgh University.
- Patients with moderate to severe renal disease (eGFR <30mL/min) who may require osteoporosis treatment should be referred for a specialist opinion.
- Long-term therapy is required to treat or prevent osteoporosis. Optimum duration is unknown but there are good safety data over 10 years for bisphosphonates. Oral bisphosphonates should be continued for 5 years in the first instance with clinical review and repeat DEXA to assess need for continued treatment at this point unless there are vertebral fractures, where therapy should be given for 10 years unless problems develop.
- Unless there is sufficient dietary intake, all patients prescribed bisphosphonates or denosumab require calcium and vitamin D/vitamin D supplementation. (Excludes patients who are at risk of hypercalcaemia e.g. sarcoidosis; have had renal stones in the last 12 months or have significant renal impairment).
- For vitamin D guidance see the Vitamin deficiency recommendations in the Nutrition and blood chapter of the formulary.
- For bisphosphonates used in malignant disease, see the Bone issues associated with malignancy recommendations in the Malignant disease and immunosuppression chapter of the formulary.
History Notes
18/05/2022
East Region Formulary content agreed.
Choice of treatment should be tailored to individual requirements. Early menopause (<50 years of age) treat with HRT or combined hormonal contraception (see prescribing notes). For institutionalized or housebound older patients, treat with Colecalciferol + Calcium carbonate.
Containing 1000mg calcium and 880 units colecalciferol. 1 tablet once daily.
Containing 1000mg calcium and 880 units colecalciferol. 1 tablet once daily.
2 caplets twice daily.
For patients who require a dispersible formulation.
1 tablet twice daily; dissolved in a glass of water and drunk immediately.
Prescribing Notes:
- Early menopause (<50 years of age) treat with HRT or combined hormonal contraception. See Menopausal symptoms recommendations in the Endocrine chapter of the formulary.
- Patients with identified risk factors for osteoporosis should be encouraged to perform weight bearing exercise and strength training, give up smoking, and follow a healthy diet with adequate calcium and vitamin D.
- Treatment with HRT or combined hormonal contraception for bone protection should be considered for early menopause up to the age of 50 years i.e. the age of natural menopause. MHRA advice remains that HRT is not first line therapy for long term prevention of osteoporosis in women who are over 50 years of age. However, for most women the benefits of HRT outweigh the small risks up to the age of 60 years and women will gain bone protection if they are taking HRT for symptom relief.
- Calcium and vitamin D supplementation alone may reduce the risk of fracture but it is less effective than other agents. The best evidence supports its use in institutionalized or housebound elderly women.
- Compliance with calcium and vitamin D preparations is often poor due to the unpleasant taste. This should be monitored and, if patients cannot tolerate the first choice preparation, other products with the same calcium and vitamin D dose may be tried.
History Notes
18/05/2022
East Region Formulary content agreed.
The decision to treat should be tailored to individual requirements depending upon the absolute risk of fracture, the assessment of which should include DEXA scanning. Alendronic acid effervescent tablets are restricted to use in patients who are unable to swallow tablets.
70mg once weekly. Take with a full glass of water on an empty stomach at least 30 minutes before breakfast and other medication. Stand or sit upright for at least 30 minutes and do not lie down until after breakfast.
70mg once weekly. Dissolve tablet completely in at least half a glass of water. Take the solution on an empty stomach at least 30 minutes before breakfast and other medication. Then take a further drink of water (at least a sixth of a glass). Stand or sit upright for at least 30 minutes and do not lie down until after breakfast.
Adcal D3 effervescent tablets are only appropriate for patients who require a dispersible formulation.
Containing 1000mg calcium and 880 units colecalciferol. 1 tablet once daily.
Containing 1000mg calcium and 880 units colecalciferol. 1 tablet once daily.
2 caplets twice daily.
1 tablet twice daily; dissolved in a glass of water and drunk immediately.
The decision to treat should be tailored to individual requirements depending upon the absolute risk of fracture, the assessment of which should include DEXA scanning.
35mg once weekly. Take with a full glass of water on an empty stomach at least 30 minutes before breakfast and other medication. Stand or sit upright for at least 30 minutes and do not lie down until after breakfast.
Adcal D3 effervescent tablets are only appropriate for patients who require a dispersible formulation.
Containing 1000mg calcium and 880 units colecalciferol. 1 tablet once daily.
Containing 1000mg calcium and 880 units colecalciferol. 1 tablet once daily.
2 caplets twice daily.
1 tablet twice daily; dissolved in a glass of water and drunk immediately.
Specialist use, in postmenopausal women who are unsuitable or unable to take standard oral osteoporosis medication.
5mg once yearly as a single dose.
Specialist initiation in postmenopausal women with a bone mineral density T-score < -2.5 and ≥ -4.0, who unsuitable or unable to take oral bisphosphonates. Adequate intake of calcium and vitamin D is important in patients taking denosumab.
60mg every 6 months, by subcutaneous injection. Supplement with calcium and vitamin D. Administer into the thigh, abdomen or upper arm.
The decision to treat should be tailored to individual requirements depending upon the absolute risk of fracture, the assessment of which should include DEXA scanning.
150mg once a month.
150mg once a month.
Adcal D3 effervescent tablets are only appropriate for patients who require a dispersible formulation.
Containing 1000mg calcium and 880 units colecalciferol. 1 tablet once daily.
Containing 1000mg calcium and 880 units colecalciferol. 1 tablet once daily.
2 caplets twice daily.
1 tablet twice daily; dissolved in a glass of water and drunk immediately.
Prescribing Notes:
- Older patients with osteoporosis, who can comply with administration instructions and have no contraindications, should be given bisphosphonates. Calcium and vitamin D supplementation alone may reduce the risk of fracture but it is less effective than other agents. The best evidence supports its use in institutionalized or housebound older patients.
- Oral bisphosphonates should be avoided in anyone with a history of oesophageal stricture or severe oesophagitis.
- Alendronate is first choice oral bisphosphonate. In patients without a history of gastro-oesophageal disease there is no convincing evidence that risedronate has any clinical advantage over alendronate. Consider risedronate in patients with intolerance to alendronate.
- Renal function should be considered when prescribing oral bisphosphonates. Consult relevant summary of product characteristics for information.
- Bisphosphonates have complex administration instructions. GI side effects are minimised by following these instructions.
- Raloxifene or monthly oral ibandronate are alternative options for younger patients (<65 years) who have predominantly spinal osteoporosis.
- Compliance with calcium and vitamin D preparations is often poor due to the unpleasant taste. This should be monitored and, if patients cannot tolerate the first choice preparation, other products with the same calcium and vitamin D dose may be tried.
- Denosumab has been associated with rare cases of atypical femoral fractures (see BNF). Patients should be advised to report any pain in the hip, thigh or groin region.
- It is important to ensure that denosumab is not co-prescribed with oral bisphosphonates.
- Evaluate a patient’s individual factors for benefits and risks before initiating treatment with denosumab 60mg, particularly in those with previous vertebral fracture. Patients should not stop denosumab without specialist review. For further advice see MHRA Drug Safety Update, August 2020.
History Notes
21/02/2023
Update to alendronic acid effervescent tablet prescribing information, ERFC Nov 22.
18/05/2022
East Region Formulary content agreed.
Patients likely to receive 7.5mg or more of prednisolone daily for 3 months or longer (or equivalent dose of other glucocorticoid) should consider prophylaxis against osteoporosis. Alendronic acid effervescent tablets are restricted to use in patients who are unable to swallow tablets.
70mg once weekly. Take with a full glass of water on an empty stomach at least 30 minutes before breakfast and other medication. Stand or sit upright for at least 30 minutes and do not lie down until after breakfast.
70mg once weekly. Dissolve tablet completely in at least half a glass of water. Take the solution on an empty stomach at least 30 minutes before breakfast and other medication. Then take a further drink of water (at least a sixth of a glass). Stand or sit upright for at least 30 minutes and do not lie down until after breakfast.
Adcal D3 effervescent tablets are only appropriate for patients who require a dispersible formulation.
Containing 1000mg calcium and 880 units colecalciferol. 1 tablet once daily.
Containing 1000mg calcium and 880 units colecalciferol. 1 tablet once daily.
2 caplets twice daily.
1 tablet twice daily; dissolved in a glass of water and drunk immediately.
Prescribing Notes:
- Older patients with osteoporosis, who can comply with administration instructions and have no contraindications, should be given bisphosphonates. Calcium and vitamin D supplementation alone may reduce the risk of fracture but it is less effective than other agents. The best evidence supports its use in institutionalized or housebound older patients.
- Oral bisphosphonates should be avoided in anyone with a history of oesophageal stricture or severe oesophagitis.
- Alendronate is first choice oral bisphosphonate. In patients without a history of gastrooesophageal disease there is no convincing evidence that risedronate has any clinical advantage over alendronate. Consider risedronate in patients with intolerance to alendronate.
- Bisphosphonates have complex administration instructions. GI side effects are minimised by following these instructions.
- Patients over 65 years should receive treatment as above. Consider DEXA scan to provide a baseline assessment.
- Patients under 65 years should have a DEXA scan. Treatment should be offered if they have osteoporosis already with t score less than -2.5, or have osteopenia with t score between -1.5 and -2.5.
- Compliance with calcium and vitamin D preparations is often poor due to the unpleasant taste. This should be monitored and, if patients cannot tolerate the first choice preparation, other products with the same calcium and vitamin D dose may be tried.
History Notes
21/02/2023
Edit to alendronic acid formulations, ERFC Nov 22.
18/05/2022
East Region Formulary content agreed.
Specialist referral should be considered. The decision to treat should be tailored to individual requirements depending upon the absolute risk of fracture, the assessment of which should include DEXA scanning. Alendronic acid effervescent tablets are restricted to use in patients who are unable to swallow tablets.
70mg once weekly. Take with a full glass of water on an empty stomach at least 30 minutes before breakfast and other medication. Stand or sit upright for at least 30 minutes and do not lie down until after breakfast.
70mg once weekly. Dissolve tablet completely in at least half a glass of water. Take the solution on an empty stomach at least 30 minutes before breakfast and other medication. Then take a further drink of water (at least a sixth of a glass). Stand or sit upright for at least 30 minutes and do not lie down until after breakfast.
Specialist referral should be considered. The decision to treat should be tailored to individual requirements depending upon the absolute risk of fracture, the assessment of which should include DEXA scanning.
35mg once weekly. Take with a full glass of water on an empty stomach at least 30 minutes before breakfast and other medication. Stand or sit upright for at least 30 minutes and do not lie down until after breakfast.
Adcal D3 effervescent tablets are only appropriate for patients who require a dispersible formulation.
Containing 1000mg calcium and 880 units colecalciferol. 1 tablet once daily.
Containing 1000mg calcium and 880 units colecalciferol. 1 tablet once daily.
2 caplets twice daily.
1 tablet twice daily; dissolved in a glass of water and drunk immediately.
Prescribing Notes:
- Older patients with osteoporosis, who can comply with administration instructions and have no contraindications, should be given bisphosphonates. Calcium and vitamin D supplementation alone may reduce the risk of fracture but it is less effective than other agents. The best evidence supports its use in institutionalized or housebound older patients.
- Male osteoporosis is often secondary to other medical conditions and specialist referral should be considered, especially in patients less than 70 years.
- Compliance with calcium and vitamin D preparations is often poor due to the unpleasant taste. This should be monitored and, if patients cannot tolerate the first choice preparation, other products with the same calcium and vitamin D dose may be tried.
History Notes
21/02/2023
Edit to alendronic acid formulations and change to order of choices, ERFC Nov 22.
18/05/2022
East Region Formulary content agreed.
Specialist use only, for severe osteoporosis. The MHRA advises that biosimilar products should be prescribed by brand name.
20 micrograms daily, by subcutaneous injection for maximum duration of treatment of 24 months.
20micrograms daily, by subcutaneous injection for maximum duration of treatment of 24 months.
20micrograms daily, by subcutaneous injection for maximum duration of treatment of 24 months.
Specialist use only, for severe osteoporosis. The MHRA advises that biosimilar products should be prescribed by brand name.
210mg once a month for 12 months by subcutaneous injection. To be administered as two consecutive 105mg injections at different injection sites into the thigh, abdomen or upper arm.
History Notes
31/10/2024
Update to prescribing information, ERFC Oct 2024
18/05/2022
East Region Formulary content agreed.
In severe conditions a bisphosphonate in addition to calcium and vitamin D OR to manage hypercalcaemia.
For dose follow specialist advice.
For dose follow specialist advice.
For dose see BNFc and follow specialist advice.
For dose see BNFc and follow specialist advice.
For dose see BNFc and follow specialist advice.
Prescribing Notes:
- Primary osteoporosis in children is under specialist management, conditions include osteogenesis imperfecta and idiopathic juvenile osteoporosis.
- Refer to guidance in British Society for Paediatric Endocrinology and Diabetes.
- The aim of treatment is the prevention of fracture.
- Before starting treatment, any disturbances of calcium or mineral deficiency should be corrected and calcium concentration should be monitored during treatment.
- Initiation, monitoring and duration of treatment follows specialist instruction.
Bisphosphonates
- See NHS Lothian Endocrinology documents for the Guideline for the administration of zoledronic acid for more information (NHS Lothian intranet).
- The long term effects of bisphosphonates in children have not been established.
History Notes
29/02/2024
East Region Formulary content agreed.
Option 1: vitamin D as colecalciferol with or without a separate calcium supplement.
See guideline for dosing: see BNFc/product literature for different brands available and for the maximum daily dosing (as this differs between brands).
See guideline for dosing: see BNFc/product literature for different brands available and for the maximum daily dosing (as this differs between brands).
See guideline for dosing: see BNFc/product literature for different brands available and for the maximum daily dosing (as this differs between brands).
See guideline for dosing: see BNFc/product literature for different brands available and for the maximum daily dosing (as this differs between brands).
See guideline for dosing: see BNFc/product literature for different brands available and for the maximum daily dosing (as this differs between brands).
See guideline for dosing: see BNFc/product literature for different brands available and for the maximum daily dosing (as this differs between brands).
See guideline for dosing: see BNFc/product literature for different brands available and for the maximum daily dosing (as this differs between brands).
See guideline for dosing: see BNFc/product literature for different brands available and for the maximum daily dosing (as this differs between brands).
See guideline for dosing: see BNFc/product literature for different brands available and for the maximum daily dosing (as this differs between brands).
12-18 years, one tablet (12.5mmol calcium) three times a day.
Dissolve one (25mmol calcium) tablet in 25ml of water = 1mmol/ml and give:
1 month to 4 years: 0.25mmol/kg four times a day.
5-12 years: 0.2mmol/kg four times a day (max 40mmol/day).
12-18 years: 12.5mmol three times a day.
Option 2: a combined calcium and vitamin D preparation.
Dosed according to the deficit or daily maintenance requirements (consult product literature).
Dosed according to the deficit or daily maintenance requirements (consult product literature).
Dosed according to the deficit or daily maintenance requirements (consult product literature).
Dosed according to the deficit or daily maintenance requirements (consult product literature).
Dosed according to the deficit or daily maintenance requirements (consult product literature).
Option 3: vitamin D as intramuscular ergocalciferol with or without a separate calcium supplement. Where compliance may be an issue.
For treatment of vitamin D deficiency. By intramuscular injection 300,000 units, can be repeated 3 monthly.
12-18 years, one tablet (12.5mmol calcium) three times a day.
Dissolve one (25mmol calcium) tablet in 25ml of water = 1mmol/ml and give:
1 month to 4 years: 0.25mmol/kg four times a day.
5-12 years: 0.2mmol/kg four times a day (max 40mmol/day).
12-18 years: 12.5mmol three times a day.
In severe conditions a bisphosphonate in addition to calcium and vitamin D OR to manage hypercalcaemia.
For dose follow specialist advice.
For dose follow specialist advice.
For dose see BNFc and follow specialist advice.
For dose see BNFc and follow specialist advice.
For dose see BNFc and follow specialist advice.
Prescribing Notes:
- Secondary osteoporosis refers to osteoporosis due to a secondary cause e.g. inflammatory disorders, immobilisation, or corticosteroids.
- Initiation of treatment and monitoring of treatment for bone metabolism disorders in children is under specialist guidance.
- Refer to guidance in British Society for Paediatric Endocrinology and Diabetes.
- The aim of treatment is the prevention of fracture.
- Before starting treatment, any disturbances of calcium or mineral deficiency should be corrected and calcium concentration should be monitored during treatment.
- Initiation, monitoring and duration of treatment follows specialist instruction.
Bisphosphonates
- See NHS Lothian Endocrinology documents for the Guideline for the administration of zoledronic acid for more information (NHS Lothian intranet).
- The long term effects of bisphosphonates in children have not been established.
History Notes
29/02/2024
East Region Formulary content agreed.