Postmenopausal Osteoporosis Clinical Trial
Official title:
Resolution of Hyperparathyroidism With High-dose Vitamin D Improves Osteoporosis in Multi-treated Postmenopausal Women
Recently, an increase in the prevalence of hyperparathyroidism and hypovitaminosis D in postmenopause women has been occurring in Mexico and the world. Chronic exposure to the parathyroid hormone (PTH) is catabolic for the bone, worsening the state of osteoporosis. However, it is unclear whether these conditions could significantly improve bone mineral density (BMD). In the present work, it was shown that the resolution of hyperparathyroidism in postmenopausal women improves osteoporosis.
This study was an open clinical trial conducted in Mexican women diagnosed with postmenopausal osteoporosis and hyperparathyroidism associated or not with hypovitaminosis D from the climacteric clinic of the regional hospital "1o de Octubre" of the Institute of Security and Social Services for State Workers (ISSSTE). An integral clinical evaluation with PTH and vitamin D measurement was first done to determine the frequency of primary hyperparathyroidism and hypovitaminosis D. Likewise, a thyroid ultrasound was done. Then, 8000 IU of vitamin D were orally administrated for four weeks. Statical analysis was performed using PAST 3.0 and GraphPad Prism 8.4.3. software. The arithmetic median (µ) and standard deviation (S.D.) were calculated using Excel-Word. Graphics were constructed with GraphPad Prism 8.4.3 and tables with Excel-Word. Categorical variables were analysed with chi-squared or Fisher exact test depending on the number of participants in each cell. Normality was determined using the Shapiro-Wilk test. To compare two paired samples, the Wilcoxon signed-rank test was utilized. To perform correlations, the Spearman correlation coefficient was used. The assigned α value for this study was <0.05. In all cases, if a Montecarlo permutation was available, the exact p-value was taken instead of the raw p-value. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05902078 -
Eldecalcitol and Calcitriol in Postmenopausal Women With Low Bone Mineral Density or Mild Osteoporosis
|
Phase 4 | |
| Completed |
NCT05087030 -
Comparative Efficacy and Safety Study of RGB-14-P and Prolia® in Women With Postmenopausal Osteoporosis
|
Phase 3 | |
| Completed |
NCT01544894 -
Clinical Study of Raloxifene and Strontium Ranelate in Postmenopausal Osteoporosis
|
Phase 4 | |
| Completed |
NCT00377819 -
Study of Transitioning From Alendronate to Denosumab
|
Phase 3 | |
| Completed |
NCT00381251 -
Study Comparing Bioequivalence of Two New Formulations of Premarin/MPA With Premarin/MPA Reference Formulation.
|
Phase 1 | |
| Completed |
NCT00239629 -
Teriparatide and Strontium Ranelate Head-To-Head Comparison Trial
|
Phase 4 | |
| Completed |
NCT04026256 -
Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration
|
Phase 4 | |
| Terminated |
NCT00529373 -
A Study of MK-0822 in Postmenopausal Women With Osteoporosis to Assess Fracture Risk (MK-0822-018)
|
Phase 3 | |
| Completed |
NCT00092014 -
A Study to Evaluate and Compare Alendronate and Risedronate on Bone Mineral Density in Women With Postmenopausal Osteoporosis (MK-0217-211)
|
Phase 3 | |
| Recruiting |
NCT06079476 -
A Study of Romosozumab (EVENITY®) in Postmenopausal Women in India With Osteoporosis at a High Risk of Fracture.
|
Phase 4 | |
| Not yet recruiting |
NCT04719650 -
Clinical Pharmacokinetics and Pharmacodynamics Study of Different Doses of Zoledronic Acid
|
Phase 4 | |
| Recruiting |
NCT02981732 -
CLCF1 Gene Associated With Postmenopausal Osteoporosis of Kidney Yin Deficiency Syndrome
|
N/A | |
| Completed |
NCT01709110 -
VERtebral Fracture Treatment Comparisons in Osteoporotic Women
|
Phase 4 | |
| Completed |
NCT01348243 -
Efficacy Of Clodronate 200 Mg/4 Ml I.M. Solution With 1% Lidocaine Every Other Week Vs Clodronate 100 Mg/3,3ml I.M. Solution With 1% Lidocaine Once-Week In A 1-Year Treatment Period Of Women With Postmenopausal Osteoporosis
|
Phase 3 | |
| Completed |
NCT00541658 -
A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis
|
Phase 3 | |
| Completed |
NCT00395395 -
Effects of Water and Food Intake on the Pharmacokinetics and Pharmacodynamics of Oral Salmon Calcitonin in Healthy Postmenopausal Women
|
Phase 1 | |
| Completed |
NCT00247273 -
A Study of Monthly Risedronate for Osteoporosis
|
Phase 3 | |
| Active, not recruiting |
NCT03720886 -
G56W1 in Women With Postmenopausal Osteoporosis
|
Phase 1/Phase 2 | |
| Completed |
NCT01668589 -
Observational Study of Denosumab (Prolia®) in Postmenopausal Women With Osteoporosis
|
N/A | |
| Completed |
NCT04664959 -
A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis
|
Phase 3 |