Zoledronic Acid 5 mg (Reclast)

Criteria for Use: Osteoporosis & Paget's Disease

VHA Pharmacy Benefits Management Service and the Medical Advisory Panel

*The following recommendations are based on current medical evidence.
The content of the document is dynamic and will be revised as new
clinical data become available. The purpose of this document is to
assist practitioners in clinical decision making, to standardize and
improve the quality of patient care, and to promote cost-effective drug
prescribing. The clinician, however, must make the ultimate judgment
regarding the propriety of any course of treatment in light on
individual patient situations.*

Due to the infrequency and location of administration,
facilities/pharmacies should ensure that the zoledronic acid appears on
the patient's medication profile so all providers are aware of the
patient's exposure (e.g., Dental Services).

[Exclusion Criteria (If any one criterion is met):]{.underline}

-   Patient does not have diagnosis of osteoporosis or Paget's disease.

-   Patient has a history of hypersensitivity reactions, including
    urticaria or angioedema, following previous infusions of zoledronic
    acid. \*

-   Patient is hypocalcaemic or has a pre-existing disturbance of
    mineral metabolism (e.g., hypoparathyroidism, thyroid or parathyroid
    surgery, vitamin D deficiency, malabsorption syndromes, excision of
    small intestine) that has not been effectively corrected or
    treated.\*

-   Patient has had a recent dental procedure such as a tooth extraction
    that increases the risk for osteonecrosis of the jaw. When in
    question, patients should be referred to Dental Services.\*

> (See
> <http://vaww1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1717>)

-   Patient's creatinine clearance is \<35 mL/min.\*

[Inclusion Criteria:]{.underline}

*General Inclusion Criteria (all must be met for all uses):*

-   Provider ordering zoledronic acid has examined the patient's oral
    cavity to screen for decay, trauma or other conditions which may
    increase the risk of osteonecrosis of the jaw prior to receiving
    each dose.\* When findings are questionable, patients should be
    referred to Dental Services. (
    <http://vaww1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1717>)

-   Patient's total daily dietary and supplemental elemental calcium
    intake is 1000 to 1500 mg/day.

-   Patient has a 25-hydroxyvitamin D concentration [\>]{.underline}25
    ng/mL AND an active prescription for cholecalciferol (Vitamin D~3~)
    or ergocalciferol (Vitamin D~2~) to prevent deficiency. For example,
    cholecalciferol [\>]{.underline}800 IU per day.\*

PLUS ONE OF THE FOLLOWING USES:

*Osteoporosis [without]{.underline} a history of recent hip fracture*

-   Patient has a history of upper GI injury or intolerance to an oral
    bisphosphonate

> **[OR]{.smallcaps}**

-   Patient has an increased risk for upper GI injury from an oral
    bisphosphonate due to a co-morbid (e.g., esophageal mobility
    disorder), or physical condition (e.g., cannot sit-up for the
    required time period following oral dosing) or nonfunctioning
    gastrointestinal tract (e.g., enteral feeding via a gastric or
    jejunostomy tube).

> **[PLUS ONE OF THE FOLLOWING]{.smallcaps}**:

-   Patient has a hip, spine, or radius T-score [\<]{.underline} -2.5

> **[OR]{.smallcaps}**

-   History of low trauma/fragility fracture independent of T-score

> **[OR]{.smallcaps}**

-   Patient previously received zoledronic acid for osteoporosis (i.e.,
    annual dose).

*Recent hip fracture*

-   Patient has had an osteoporotic-related hip fracture in the past 90
    days.

> **[OR]{.smallcaps}**

-   Patient previously received zoledronic acid post hip fracture (i.e.,
    annual dose).

*Paget' Disease*

-   Patient has a diagnosis of Paget's disease.

-   Patient has orders for 1500 mg calcium and 800 IU of vitamin D daily
    for 2-weeks following infusion.

> \*For safety these criteria should be reviewed prior to each infusion.

Additional prescribing information can be found at:
[http://vaww.national.cmop.va.gov/PBM/Clinical%20Guidance/Drug%20Monographs/Zoledronic%](http://vaww.national.cmop.va.gov/PBM/Clinical Guidance/Drug Monographs/Zoledronic%25)

November 2008\
[http://www.pbm.va.gov/monograph/Zoledronic%20Acid%20(Reclast).doc](http://www.pbm.va.gov/monograph/Zoledronic Acid (Reclast).doc)\
Updated versions may be found at
[http://vaww.pbm.va.gov](http://vaww.pbm.va.gov/) or
[http://www.pbm.va.gov](http://www.pbm.va.gov/)

Prepared by Todd Semla, MS, Pharm.D., BCPS, FCCP, AGSF