This study aimed to determine

the laboratory reproducibility of two biochemical markers of bone turnover: urine cross-linked N-telopeptide of type I collagen (NTX), a marker of bone resorption, and serum bone-specific alkaline phosphatase (BAP), a marker of bone formation. Methods Postmenopausal women older than 55 years of age were Lazertinib manufacturer recruited with advertising MK-8776 chemical structure flyers posted around a large academic medical center and in community businesses. Volunteers were excluded if they were using current pharmacologic therapy for osteoporosis, with relevant therapy defined as estrogen, calcitonin, a selective estrogen receptor modulator, a bisphosphonate, or teriparatide; calcium and vitamin D supplements were permitted. All volunteers provided verbal informed consent with the assistance of an information sheet, given the minimal risks involved in participation. The institutional review board of the University of California, San Francisco approved selleck kinase inhibitor the study protocol prior to initiation of the study. A pool of serum and a pool of urine were created from specimens from five volunteers, in order to create samples sufficiently large for the investigation and also in order to minimize the interfering effects of medications or other

factors specific to a single volunteer. To create the pool of serum, fasting morning blood from the participating women was collected in eight gold-top serum separator tubes, allowed to clot at room temperature for 30 min, and then placed on ice, centrifuged, and separated. The pooled serum was then stirred for 10 min in an ice water bath, divided into 1.2 mL aliquots, Bay 11-7085 and flash-frozen. To create the pool of urine, fasting second-morning urine from the participating women was collected, placed on ice, pooled, stirred for 10 min in an ice water bath, divided into 4 mL aliquots, and flash-frozen. The serum and urine aliquots were then frozen at −80°C. Six US laboratories were selected for investigation, each a recognized, high-volume commercial laboratory that offers urine NTX and

serum BAP testing: ARUP Laboratories (Salt Lake City, UT, USA), Esoterix Laboratory Services (Calabasas Hills, CA, USA), Laboratory Corporation of America (LabCorp; Burlington, NC, USA), Mayo Medical Laboratories (Rochester, MN, USA), Quest Diagnostics (Nichols Institute, San Juan Capistrano, CA, USA), and Specialty Laboratories (Valencia, CA, USA). To prevent bias, the laboratories were unaware of the investigation; source-masked identifiers were used for all specimens, and the specimens were sent by the authors’ institutional clinical laboratory as routine clinical specimens ordered by clinicians would be sent. The laboratories were paid in full via the standard contractual arrangements in place with the authors’ clinical laboratory. Each laboratory was sent a serum and a urine specimen on five dates over an 8-month period, in order to assess longitudinal (between-run) variability of the marker measurements.