Drug Formulary information is intended for use by healthcare professionals. It is not intended to be medical advice. Some of the information, including information about funding for cancer drugs, does not apply to all patients. Cancer treatment plans are unique to each patient. If you are a patient, please speak with your healthcare team to understand how this information applies to you.
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regimen-monograph
CLDN
Intent
Palliative
Regimen Category
Standard
Funding Program
ODB Limited Use
clodronate - For the control and prophylaxis of hypercalcemia of malignancy (capsules)
Drugs Used
A - Regimen Name
CLDN Regimen
Clodronate
Disease Site
Breast
Intent
Palliative
Regimen Category
Standard : Standard therapy endorsed by the Disease Site Group or a regimen widely used by most Regional Cancer Centres in this disease site. The category is unrelated to the source or availability of funding.
Rationale and Uses
Patients with metastatic breast cancer with bone metastases
Supplementary Public Funding
clodronate
ODB Limited Use (clodronate - For the treatment of bony metastases in patients with breast cancer (capsules))
clodronate
ODB Limited Use (clodronate - For the control and prophylaxis of hypercalcemia of malignancy (capsules))
clodronate
New Drug Funding Program (Clodronate (IV) - Metastatic Breast Cancer)
B - Drug Regimen
| clodronate | 1600* mg | PO on an empty stomach (at least 2 hrs before or after eating) | Daily (dose may be split into BID or QID if GI intolerance) |
|
*Dose may be increased up to 3200 mg/day if clinically appropriate. If tolerance poor, consider IV (note: clinical trials used oral formulation only). OR |
|||
| clodronate | 1500 mg | IV in 500mL NS or D5W over 4 hours | Day 1 |
C - Cycle Frequency
Oral: CONTINUOUS TREATMENT until unacceptable toxicity
IV: Q3-4 WEEKS until unacceptable toxicity *
*In the management of multiple myeloma, to reduce risk of osteonecrosis of the jaw after two years of treatment, consideration is given to either: Discontinuing treatment in patients who have responded and who have stable bone metastases OR Decreasing frequency to every three months if the patient still needs active treatment.
D - Premedication and Supportive Measures
Antiemetic Regimen:
Not applicable
Other Supportive Care:
- All patients, especially those with hypercalcemia should be adequately hydrated.
- Calcium and Vitamin D supplements should be considered in patients who have normal calcium levels with no history of hypercalcemia. (Refer to Clodronate monograph).
E - Dose Modifications
Doses should be modified according to the protocol by which the patient is being treated. The following recommendations have been adapted from clinical trials or product monographs and could be considered.
Dosage with toxicity
Dosage in myelosuppression: No dosage adjustment required
|
Toxicity
|
Action
|
Atypical fractures of the femur |
Consider discontinuing
|
Ocular symptoms other than uncomplicated conjunctivitis |
Refer to ophthalmologist; consider discontinuing |
|
Osteonecrosis of the jaw
|
Refer to dentist or dental surgeon; consider hold or discontinue |
|
Severe or intolerable GI symptoms
|
Consider discontinuing; switch to IV bisphosphonate |
Hepatic Impairment
No adjustment required.
Renal Impairment
Clodronate is renally excreted and should be discontinued if renal function deteriorates during treatment.
Creatinine Clearance |
PO: % of normal dose |
IV: % of Normal dose |
50-80 mL/min |
100% |
75-100% |
30-49 mL/min |
75% |
50-75% |
12-29mL/min |
50% |
50-75% |
< 12mL/min |
50% OR discontinue |
50% OR discontinue |
F - Adverse Effects
Refer to clodronate drug monograph(s) for additional details of adverse effects
Most Common Side Effects
|
Less Common Side Effects, but may be |
|
|
H - Drug Administration and Special Precautions
Refer to clodronate drug monograph(s) for additional details
I - Recommended Clinical Monitoring
Recommended Clinical Monitoring
- Corrected serum calcium* (daily during iv infusion), albumin, and phosphate -- *Corrected Ca (mmol/L) = Measured Ca (mmol/L) + (0.02 X [40-Measured Albumin (g/L)]); baseline and regular
- Dental examination with appropriate preventative dentistry should be considered prior to treatment. Regular dental check-ups. Avoid invasive dental surgeries while on treatment.
- Renal function tests, especially with IV use; baseline and regular
- Clinical toxicity assessment (GI, hydration, osteonecrosis, dental, hypersensitivity, ophthalmic, musculoskeletal pain)
- Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
Suggested Clinical Monitoring
- CBC, in patients with anemia, leukopenia or thrombocytopenia; Baseline and regular
- Liver function tests; Baseline and intermittent
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J - Administrative Information
Oral Clodronate: Outpatient prescription for home administration
Approximate Patient Visit
IV: 3 hours
K - References
Diel I J, Solomayer E, Costa SD, et al. Reduction in new metastases in breast cancer with adjuvant clodronate treatment. NEJM 1998; 339(6): 357-63.
Bloomfield D, Warr D, Whelan T, Pritchard K, Levine M, and the Breast Cancer Disease Site Group. Use of bisphosphonate in patients with bone metastases from breast cancer. Current Oncology 1999; 6(3): 144-154.
PEBC Advice Documents or Guidelines
October 2017 Updated dose modifications, adverse effects and monitoring
L - Other Notes
Intravenous clodronate has not been examined for its ability to reduce morbidity from bone metastases with long-term use. When clodronate is used for this purpose, the oral route is recommended.
M - Disclaimer
Regimen Abstracts
A Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). It is intended for healthcare providers and is to be used for informational purposes only. It is not intended to constitute or be a substitute for medical advice, and all uses of the Regimen Abstract are subject to clinical judgment. Such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability, and Cancer Care Ontario disclaims all liability for the use of this information, and for any claims, actions, demands or suits that arise from such use.
Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph. Full regimen monographs will be published for each ST-QBP regimen as they are developed.
Regimen Monographs
Refer to the New Drug Funding Program or Ontario Public Drug Programs websites for the most up-to-date public funding information.
The information set out in the drug monographs, regimen monographs, appendices and symptom management information (for health professionals) contained in the Drug Formulary (the "Formulary") is intended for healthcare providers and is to be used for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects of a particular drug, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for a given condition. The information in the Formulary is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.
The format and content of the drug monographs, regimen monographs, appendices and symptom management information contained in the Formulary will change as they are reviewed and revised on a periodic basis. The date of last revision will be visible on each page of the monograph and regimen. Since standards of usage are constantly evolving, it is advised that the Formulary not be used as the sole source of information. It is strongly recommended that original references or product monograph be consulted prior to using a chemotherapy regimen for the first time.
Some Formulary documents, such as the medication information sheets, regimen information sheets and symptom management information (for patients), are intended for patients. Patients should always consult with their healthcare provider if they have questions regarding any information set out in the Formulary documents.
While care has been taken in the preparation of the information contained in the Formulary, such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability.
CCO and the Formulary’s content providers shall have no liability, whether direct, indirect, consequential, contingent, special, or incidental, related to or arising from the information in the Formulary or its use thereof, whether based on breach of contract or tort (including negligence), and even if advised of the possibility thereof. Anyone using the information in the Formulary does so at his or her own risk, and by using such information, agrees to indemnify CCO and its content providers from any and all liability, loss, damages, costs and expenses (including legal fees and expenses) arising from such person’s use of the information in the Formulary.
Last Updated: July 27, 2026
