Effect of denosumab and zoledronic acid on bone turnover markers in critically ill wome

Phase 2

Recruiting

• Conditions: Critical illness; Osteoporosis; Musculoskeletal - Osteoporosis

• Registration Number: ACTRN12617000545369
• Lead Sponsor: niversity Hospital Geelong

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-18
• Last Update Posted: 30 September 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

1. Admitted to ICU
2. Female
3. Age >50 years or postmenopausal (amenorrhea for greater than 6-months or serum FSH >40mIU/L) or age < 50 years with bilateral salpingo-oopherectomy
4. Intensive care unit length of stay > 24 hrs

Exclusion Criteria

1.Active malignancy
2.Metabolic bone disease
3.Pregnancy
4.Current eGFR <30ml/min
5.Known contraindication to denosumab (previous reaction, osteonecrosis of the jaw, atypical femoral fracture)
6.Increased risk of osteonecrosis (poor dentition or oral hygiene, dental infection)
7.Hypoparathyroidism
8.Malabsorption sydnromes / extensive small bowel resection
9.Current treatment with anti-fracture agent (bisphosphonate, strontium, teriparatide, within previous 2 years or denosumab within previous 6 months)
10.Current indication for anti-fracture therapy (known BMD T-score < -2.5 and fragility fracture)
11.Death is imminent or expected in this hospital admission

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the serum bone turnover marker collagen type 1 cross-linked c-telopeptide (CTX) measured using the automated Roche Modular Analytics E170 analyser. Serum collagen type 1 cross-linked c-telopeptide limit of detection was 10 ng/L with inter-assay coefficient of variations (CVs) of 6.5% at 361 ng/L, 3.8% at 816 ng/L and 3.4% at 3304 ng/L (n = 10).[28-days after administration of study drug dose 1]