Phase 3 N=124 Use of NPSP558 in the Treatment of Hypoparathyroidism
Hypoparathyroidism
Primary: The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 24. — 2.5; 54.8 percentage of participants — p=<0.001
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 2 N=27 Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34
Hypoparathyroidism
Primary: Serum Calcium Level — 2; 1.92 mmol/liter
Phase 3 N=42 Study of Safety and Efficacy of a rhPTH[1-84] of Fixed Doses of 25 and 50 mcg in Adults With Hypoparathyroidism (RELAY)
Hypoparathyroidism
Primary: Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 8, Based on Investigator Prescribed Data. — 21.1; 26.1 percentage of participants — p=>0.999
N/A N=1,170 Adherence to PTH(1-84) Treatment (FP-002-IM)
Clinical Use of PTH(1-84)
Primary: Number of Participants Who Discontinued Before 6 Months of Treatment — 181 participants
Phase 4 N=81 Effect of Full Length Parathyroid Hormone, PTH(1-84) or Strontium Ranelate on Bone Markers in Postmenopausal Women With Primary Osteoporosis (FP-006-IM)
Osteoporosis
Primary: Percentage Change in the Bone Formation Marker N-terminal Propeptides of Human Procollagen Type I (P1NP) From Baseline to End of Trial — 446.1; -6.2 percent change…
Phase 2 N=80 Parathyroid Hormone (PTH) for Osteoporosis in Postmenopausal Women
Postmenopausal Osteoporosis · Osteoporosis
Primary: Changes in Indices of Bone Turnover — 4418; 3696; 956; 822 months*(ng/ml - baseline ng/ml)
Phase 4 N=39 A Study of Extended Use of Recombinant Human Parathyroid Hormone (rhPTH(1-84)) in Hypoparathyroidism
Chronic Hypoparathyroidism · Hypoparathyroidism
Primary: Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at Month 6 — -0.005 Millimole per liter (mmol/L)
Phase 3 N=407 Sequential Treatment of Postmenopausal Women With Primary Osteoporosis (FP-001-IM)
Osteoporosis
Primary: Change in Lumbar Spine BMD From Start of Trial Period III Until End of Trial Period III. — 1.002; 0.990 Percentage Change — p=0.010
Phase 4 N=93 A Study to Learn if Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Can Improve Symptoms and Metabolic Control in Adults With Hypoparathyroidism (BALANCE)
Hypoparathyroidism
Primary: Change From Baseline in Hypoparathyroidism Symptom Diary (HypoPT-SD) Symptom Subscale Score at Week 26 — -0.93; -1.46 score on a scale — p==0.003
Phase 2 N=105 Comparison Study of PTHrP and PTH to Treat Osteoporosis
Osteoporosis
Primary: Procallagen-1 Amino-terminal Peptide (P1NP) — 32.54; 23.51; 60.67; 48.89 percentage change from baseline — p=<0.0005
Early Phase 1 N=11 7 Day Continuous Parathyroid Hormone IV Infusion
Osteoporosis · Bone Diseases, Endocrine · Hyperparathyroidism
Primary: Participants With Dose Limiting Toxicity — 0; 2 participants
Phase 2 N=20 Comparing Pump With Subcutaneous Injection Delivery of PTH 1-34 in the Management of Chronic Hypoparathyroidism
Hypoparathyroidism · Hypocalcemia · Autoimmune Polyendocrine Syndrome Type 1
Primary: Mean Serum Calcium in Children and Young Adults — 2.02; 1.88 mmol/liter — p=0.02
Phase 2 N=97 Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of PTH Analog Tablets in Postmenopausal Women
Postmenopausal Osteoporosis
Primary: % Change From Baseline BMD in L1-L4 Axial Lumbar Spine at Week 24 — 5.07; 2.21; -0.17 percentage of change
Early Phase 1 N=14 One Week Parathyroid Hormone-related Protein (PTHrP) IV Dose Escalation Study
Osteoporosis · Humoral Hypercalcemia of Malignancy · Hyperparathyroidism
Primary: Dose Limiting Toxicity (DLT) — 0; 0; 2; 2 participants
Phase 1 N=34 Study to Assess the Blood Concentrations and Actions of Recombinant Human Parathyroid Hormone (rhPTH [1-84]) When Given Once and Twice Daily to Participants With Hypoparathyroidism
Hypoparathyroidism
Primary: Time of Maximum Observed Concentration (Cmax) During a Dosing Interval (Tmax) of Baseline Adjusted rhPTH(1-84) — 7.108; 7.083; 0.333; 1.000 hours
Phase 3 N=62 HEXT (Hypo EXTended): Effect of PTH on Skeleton in Hypoparathyroidism
Hypoparathyroidism
Primary: Change in Dose of Calcium Supplementation — 37 percent change in dose
Phase 1 N=24 Study of rhPTH(1-84) in Japanese Healthy Subjects Compared With Matched Caucasian Healthy Adult Subjects
Hypoparathyroidism
Primary: Baseline-adjusted Cmax of PTH(1-84) — 295.662; 330.820; 175.468; 99.708 Picogram per milliliter (pg/mL)
Phase 4 N=65 A Pilot Clinical Study Evaluating the Effect of Parathyroid Hormone (PTH) Lowering On Erythropoietin Consumption in Calcitriol-Resistant Patients
Moderate to Severe Secondary Hyperparathyroidism · Stage 5 Chronic Kidney Diseases
Primary: Mean Erythropoietin Dose Per Visit — 35.8; 22.2; 22.7; 4.7 µg
Phase 3 N=51 A Open-label Study Investigating the Safety and Tolerability of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH [1-84]), for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study (RACE)
Hypoparathyroidism
Primary: Number of Participants With Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE) — 13; 48 Participants
Phase 1 N=84 A Study of Relative Bioavailability of a New Formulation Compared With the Approved Formulation of rhPTH [1-84] and to Find Out Dose Linearity of the New Formulation in Healthy Adults
Healthy Volunteers
Primary: Part I: Area Under the Plasma Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of rhPTH (1-84) — 471.9; 603.1…
Phase 2 N=10 PTH-independent Effects of Encaleret
Post-Surgical Hypoparathyroidism
Primary: Percent Change in Fractional Excretion of Calcium (FECa) — -39 percentage of change
Phase 3 N=82 A Trial Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Daily in Adults With Hypoparathyroidism
Hypoparathyroidism · Endocrine System Diseases · Parathyroid Diseases
Primary: Efficacy - Primary Endpoint During the Blinded Period — 78.7; 4.8 Percentage of participants — p=<0.0001
Phase 3 N=31 Combination Risedronate - Parathyroid Hormone Trial in Male Osteoporosis
Osteoporosis
Primary: Change in Spine Bone Density — 6.95; 3.76; 5.68 % change in LS BMD
Phase 4 N=49 Risedronate and Parathyroid Hormone to Reverse Osteoporosis Caused by Chronic Steroid Use
Osteoporosis
Primary: Bone Mineral Density (BMD): Examine the Pattern and Effect of BMD Changes at Hip and Spine Measured by DXA Every 6 Months. — 0.85; 0.84; 0.91 percent change
Phase 2 N=59 A Trial Investigating the Safety, Tolerability and Efficacy of TransCon PTH in Adults With Hypoparathyroidism
Hypoparathyroidism · Endocrine System Diseases · Parathyroid Diseases
Primary: Efficacy - Primary Endpoint During the Blinded Period — 50.0; 40.0; 60.0; 26.7 Percentage of participants — p== 0.2635
Phase 2 N=35 PTH(1-34) and Pelvic Fracture Healing - a Randomized Controlled Trial
Osteoporotic Fractures
Primary: Number of Participants With Evidence of Cortical Bridging for Fracture Healing — 9; 8 Participants
Phase 3 N=46 Treatment of Primary Hyperparathyroidism With Denosumab and Cinacalcet.
Primary Hyperparathyroidism · Parathyroid Adenoma · Parathyroid Hyperplasia
Primary: Change in Lumbar Spine Bone Mineral Density — 0.030; 0.042; -0.016 g/cm^2 — p=< 0.00001
Phase 4 N=100 Effectiveness and Safety of IV Zemplar in Patients on Hemodialysis and With Secondary Hyperparathyroidism Using iPTH/100 as Initial Dose
Secondary Hyperparathyroidism · Renal Insufficiency, Chronic · Parathyroid Hormone
Primary: The Percentage of Patients Reaching at Least a 30% Reduction in PTH and/or Values in Range 150-300 pg/mL — 96.6 Percentage of participants
Phase 3 N=33 Effectiveness of Paricalcitol in Reducing Parathyroid Hormone (PTH) Levels in X-linked Hypophosphatemic Rickets
Hypophosphatemia, Familial · Hyperparathyroidism
Primary: Area Under the Curve for Parathyroid Hormone (PTHauc) Measurement — 1223; 1449; 987; 1616 nlEq*26hr/ml — p=0.007
Phase 3 N=68 Bone Properties in Hypoparathyroidism: Effects of PTH
Hypoparathyroidism
Primary: Requirements for Calcium Supplementation — 3.03; 1.66 grams per day of calcium supplementation