Orthopaedics  |  Fragility Fractures Pathway - Treatment




Orthopaedics

Fragility Fractures Pathway - Treatment

Treatment is only indicated for patients with a Bone Mineral Density showing osteoporosis  (T score of worse than -2.5). Although osteopenia (T score -1 to -2.5) is a risk factor for future fracture, there are currently no trials showing benefit of treatment in these patients as a group.

The following general recommendations for the treatment of osteoporosis including, secondary prevention of fragility fracture are currently considered 'best practice'.  This is not a comprehensive clinical treatment guideline. Seek advice if unsure via Nicola Ward, Fracture Prevention Service, BOPDHB, 07 557 5570 or 027 8013 723.

For all situations listed below, ensure adequate calcium and vitamin D intake.

 

  • SITUATION 1: NO PRIOR BISPHOSPHONATE

Bisphosphonate is recommended unless contraindicated (or considered inappropriate for other reasons e.g. limited life expectancy).

Choose any one of Risedronate (no special authority required), Alendronate, Zoledronic acid

(see below for differentiating factors). Etidronate is no longer recommended.

NB: Pharmaceutical manufacturers of bisphosphonates do not recommend bisphosphonates if calculated creatinine clearance (Cockroft and Gault)  <30ml/min (risedronate) or <35ml/min (alendronate, zoledronic acid).

  • SITUATION 2: CURRENTLY ON BISPHOSPHONATE OR OTHER ANTI-OSTEOPOROSIS* TREATMENT, OR BEEN SO IN LAST 3 YEARS (*teriparatide, HRT, raloxifene)

If a patient experiences a further fracture on anti-osteoporosis treatment, it is not necessarily an indication that the treatment should be changed or discontinued. Check adherence and exclude secondary causes of osteoporosis. Decision to continue or change treatment may be influenced by a number of factors including length of time patient has been on treatment and degree of worsening of BMD measurements. Consult if unsure, via HIA e-Referral or contact Fracture Prevention service as above. 

How to choose between bisphosphonates?

The following three bisphosphonates have similar licensed indications. The evidence base differs for each one but a class effect is generally assumed.


Risedronate:

  1. Good evidence to support secondary prevention for hip, vertebral and non-vertebral fractures.
  2. Low quality evidence to support secondary prevention for wrist fractures
  3. May have fewer upper GI adverse effects than alendronate (patients with GI disorders were included in clinical trials).
  4. No special authority required.

See also:


Alendronate:

  1. Good evidence to support secondary prevention for hip, vertebral and non-vertebral fractures.
  2. Low -quality evidence to support secondary prevention for wrist fractures.
  3. Good evidence to support primary prevention for vertebral fractures only.
    May have more upper GI adverse effects than risedronate (patients with GI disorders were excluded from clinical trials).
  4. Needs Pharmac special authority number.*

 

*Find the 'Alendronate Tab 70 mg - with or without Cholecalciferol' Special Authority Form under the 'Musculoskeletal System' heading on the Pharmac 'Special Authority Forms' webpage.

See also:


Zoledronic Acid:

  1. IV; may be useful if problems with adherence, absorption, ability to comply with oral administration requirements, (e.g. in dementia, cognitive impairment, memory loss), severe GI problems e.g. acute oesophageal/gastric inflammation or ulceration, oesophageal strictures, achalasia, scleroderma.
  2. GP practices charge a fee to administer IV, cost may be a barrier for some patients.
  3. Zoledronate is an IV bisphosphonate that reduces risk of hip, vertebral and non-vertebral fractures.5 In the pivotal clinical trials, Zoledronate was administered annually for three years. However, Zoledronate’s duration of action is considerably longer than one year; therefore, it is common practice to administer the three initial doses at intervals of 18 or 24 months.
  4. Contraindicated if calculated creatinine clearance (Cockroft and Gault) <35ml/min. Can cause deterioration in renal function in patients with pre-existing renal impairment. See IV administration protocol for more informationContraindications to Zoledronate include: creatinine clearance or eGFR <35 mL/min; marked vitamin D deficiency; and
    hypocalcaemia.
  5. The most common side effect of Zoledronate is post-dose flu-like symptoms (affecting approximately 30% of patients), the majority of which occur within the first 3 days following Zoledronate administration and resolve within 3 days. The incidence of these symptoms can be reduced with administration of paracetamol shortly after the Zoledronate dose. These symptoms decrease markedly with subsequent doses of Zoledronate (incidence of 1–2%). Ensure adequate hydration.
  6. Needs Pharmac special authority number.**

 

**Find the 'Zoledronic acid inj 0.05 mg per ml, 100mlSpecial Authority Form under the 'Musculoskeletal System' heading on the Pharmac 'Special Authority Forms' webpage.

See also:


Treatment duration & drug holidays:

Treatment review is essential as there may be an increased incidence of rare adverse effects with long-term bisphosphonate use. Review risedronate and alendronate after 5 years and zoledronic acid after 3 years.

  • Clinical trials have shown that after 3 to 5 years of bisphosphonate therapy, patients whose femoral T-score has risen above -2.5 and who have not had new fractures are able to discontinue bisphosphonate treatment for up to 5 years without an increase in their future fracture risk. Therefore, remaining off treatment for 4 to 5 years is appropriate for patients meeting these criteria.
  • Seek advice if unsure via Nicola Ward, Fracture Prevention Service, BOPDHB, 07 557 5570 or 027 8013 723.

  • Continue if high risk but re-review annually; high risk factors:
    • Prior hip or multiple vertebral fractures
    • Age ≥ 75 years
    • Continued fragility fractures on treatment
    • Total hip or femoral neck BMD T-score ≤ -2.5 at time of treatment review
    • Recurrent falls
    • Other risk factors including secondary osteoporosis, co-morbidities, oral glucocorticoids


After a total of 10 years for risedronate and alendronate  or 6 years for zoledronic acid, stop bisphosphonate but continue adjunctive therapies i.e. vitamin D, dietary advice, falls prevention.

When treatment is discontinued, fracture risk should be reassessed every two years or after a new fracture (regardless of when this occurs).

Second Line Therapy

Teriparatide
Teriparatide is a fragment of parathyroid hormone, administered by once-daily subcutaneous injection, that may be used in patients with established osteoporosis and recurrent fracture and following at least 12 months of antiresorptive therapy.

Denosumab
Denosumab is a monoclonal antibody directed against RANK-ligand, administered by subcutaneous injection every 6 months, for treatment of osteoporosis. Denosumab is not yet reimbursed in New Zealand.

Other treatments:

Selective estrogen receptor modulators (SERMS)
SERMS (e.g. raloxifene) could be considered as an alternative to oestrogen therapy in postmenopausal women, although raloxifene does not prevent hip or other non-vertebral fractures.

Strontium ranelate
Strontium ranelate is not recommended because of its adverse cardiovascular profile.

If considering treatment with Teriparatide please ensure patient meets Pharmac special authority criteria*** for eligibility, and if the patient is eligible refer to the Fracture Prevention Service via Health in Ageing eReferral (Annotate referral with Fracture Prevention Service).

***Find the 'TeriparatideSpecial Authority Form under the 'Musculoskeletal System' heading on the Pharmac 'Special Authority Forms' webpage.

 



Last updated : Wednesday, November 22, 2017
Next review date : Thursday, November 22,2018


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