Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 6 Months
Time frame · Baseline, 6 Months
Registry description
Bone mineral density (BMD) of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar). Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.
Time Course Change of BMD Response at the Lumbar Spine
Time frame · Baseline to 6 Months and 12 Months
Registry description
To assess the time course of the treatment, the BMD data of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA) and analyzed using a mixed model repeated measures (MMRM) method, with the repeated measure occurring at each visit (for example, 6 and 12 month). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar).
Percent Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP)
Time frame · Baseline, 1 Month, 3 Months, 6 Months, 12 Months
Registry description
Procollagen Type 1 N-Terminal Propeptide (P1NP) is a marker of bone formation.
Percent Change From Baseline of C-Terminal Telopeptide (CTX)
Time frame · Baseline, 1 Month, 3 Months, 6 Months, 12 Months
Registry description
C-terminal telopeptide is a marker of bone resorption.
Percent Change From Baseline in Serum Procollagen Type 1 C-Propeptide (P1CP) at 1 Month
Time frame · Baseline, 1 Month
Registry description
Procollagen Type 1 N-Terminal Propeptide (P1NP) is a marker of bone formation.
Convenience/Ease of Use Questionnaire (CEUQ)
Time frame · baseline up to 12 months
Registry description
CEUQ consists of 5 sections and 16 questions using a 5-point Likert scale designed to collect measures for ease of use (S1), convenience of use (S2), confidence of use (S3), fear of use (S4), and overall satisfaction with therapy (S5). CEUQ is not a validated instrument.
Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours
Time frame · Baseline, 12 Months
Registry description
Serum calcium adjusted for serum albumin levels is calculated using the following formula: Total Calcium + \[(40 - albumin) x 0.02\]. Analysis for serum calcium and albumin adjusted serum calcium were collected at predose, 4 hours (h) post-dose (PD) and 6 h PD at baseline and 12 months (mon).
Change From Baseline in Urine Calcium Excretion at 6 and 12 Months
Time frame · Baseline, 6 Months, 12 Months
Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon)
Time frame · Pre-Dose, 30 minutes, 2 hours Post-Dose at Baseline and 12 Months
Registry description
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) measured at pre-dose and 30 minutes (min) and 2 hours (hr) post-dose in both the supine and standing position.
Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon).
Time frame · Pre-dose, 30 minutes, 2 hours at Baseline and 12 Months
Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels
Time frame · Baseline and 1, 3, 12, and 13 Months (mon)
Registry description
Participants were tested for anti-recombinant teriparatide and anti-synthetic teriparatide titers. Either none were detected (ND) or antibodies were determined to be present if the teriparatide specific antibody titers were at least 1:8 (titer 1:8).
Pharmacokinetics Parameters: Area Under the Curve (AUC)
Time frame · Baseline, 1 Month, 3 Months, and 12 Months
Registry description
Due to high intra-subject variability, data was not analyzed for this outcome measure.
Pharmacokinetics Parameters: Maximal Concentration (Cmax)
Time frame · Baseline, 1 Month, 3 Months, 12 Months
Registry description
Due to high intra-subject variability, data was not analyzed for this outcome measure.
DRAIZE Edema Assessment at Baseline Through 13 Month Follow-up
Time frame · 13 Month follow-up
Registry description
Severity of edema was categorized based on a 5 point scale: 0=no edema, 4=severe edema (defined as an area raised more than 1 millimeter and extending beyond area of exposure)
DRAIZE Erythema Assessment at Baseline Through 13 Month Follow-up
Time frame · 13 Month follow-up
Registry description
Severity of erythema was categorized based on a 5 point scale: 0=no erythema, 4=severe erythema (defined as beet red to eschar)