Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Amgen
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Hypercalcemia of Malignancy (HCM) as defined as documented histologically or cytologically confirmed cancer and a corrected serum calcium (CSC) \> 12.5 mg/dL (3.1 millimoles /L) at screening by local laboratory
Last IV bisphosphonate treatment must be \>/= to 7 days and \</= to 30 days before the screening corrected serum calcium
Adults (\>/=18 years)
Adequate organ function as defined by the following criteria:
serum aspartate aminotransferase (AST) \</= 5 x upper limit of normal (ULN)
serum alanine aminotransferase (ALT) \</= 5 x upper limit of normal
serum total bilirubin \</= 2 x upper limit of normal
You may not be if
Evidence of benign hyperparathyroidism, hyperthyroidism, adrenal insufficiency, vitamin D intoxication, milk alkali syndrome, sarcoidosis, or other granulomatous disease
Receiving dialysis for renal failure
Treatment with thiazides, calcitonin, mithramycin, or gallium nitrate within their window of expected therapeutic effect (as determined by the physician) prior to the date of the screening CSC
Treatment with cinacalcet within 4 weeks prior to the date of the screening CSC
Thirty days or less since receiving an investigational product (other than denosumab) or device (ie, does not have marketing authorization; thalidomide use is allowed) in another clinical study
Known sensitivity to any of the products to be administered during the study (eg, mammalian derived products)
Female subject is pregnant or breast feeding, or planning to become pregnant within 7 months after the end of treatment
Female subject of childbearing potential is not willing to use 2 highly effective methods of contraception during treatment and for 7 months after the end of treatment
Subject will not be available for follow-up assessment.
Any organic or psychiatric disorder that, in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results
Clareo Health | Study of Denosumab in the Treatment of Hypercalcemia of Malignancy in Subjects With Elevated Serum Calcium
