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Osteopenia clinical trials

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NCT ID: NCT03999775 Completed - Osteopenia Clinical Trials

Effect of Calcium and Vitamin D Supplementation With and Without Collagen Peptides in Postmenopausal Women With Osteopenia

Start date: January 14, 2017
Phase: N/A
Study type: Interventional

Osteoporosis is undoubtedly one of the most common diseases affecting older individuals with debilitating consequences. Osteopenia, defined as T-score between -1 and -2.5, has also been associated with increased risk of osteoporotic fractures and the associated morbidity and mortality. Prompt diagnosis, prevention and treatment of both osteopenia and osteoporosis are essential in order to minimize future fracture risk. The mainstay of treatment of osteopenia and osteoporosis includes dietary changes, regular weight-bearing exercises, calcium and vitamin D supplementation and pharmacologic treatment mainly with antiresorptive or anabolic agents. Collagen peptides (CPs), also called collagen hydrolysates produced by hydrolysis of collagen, have also been shown to have high oral bioavailability and could have a place as a treatment option. Type I collagen comprises approximately 95% of the entire collagen content of bone. Bone matrix, unlike other connective tissues, possesses the unique ability to become calcified. Spindle or plate-shaped crystals of hydroxyapatite are found between and around collagen fibers, oriented in the same direction as collagen fibers are. Nowadays, it is well-documented that type I collagen molecules are involved in the mechanical properties of bone. Collagen peptide compounds seem to exert their beneficial effect on bone by affecting bone remodeling and mineralization of the bone matrix, promoting the proliferation and differentiation of pre-osteoblasts while reducing the maturation of osteoclasts. Several preclinical studies performed in mice and rats support this notion and also suggested that orally administrated CPs increased bone mineral density (BMD), as well as the compositional and the biodynamic characteristics of vertebrae. Human studies in postmenopausal women have also yielded positive results with increased BMD and blood biomarkers after 6 months and 1 year of oral administration. The aim of the present randomized prospective study was to examine and compare the efficacy, as represented by the changes in bone biomarkers procollagen type I N-terminal propeptide (P1NP) and C-terminal telopeptide of collagen I (CTX), and bone mineral density and the tolerability of supplementation of calcium, vitamin D with and without bioactive CPs for a year in postmenopausal women with osteopenia.

NCT ID: NCT03925532 Completed - Osteoporosis Clinical Trials

Denosumab in Treating Patients With Bone Loss Due to Donor Stem Cell Transplant

Start date: December 19, 2019
Phase: Phase 2
Study type: Interventional

This Phase II trial studies the side effects of denosumab and to see how well it works in treating patients with bone loss who have received a donor stem cell transplant. Patients receiving a donor stem cell transplant may experience accelerated bone loss and an increase risk of bone fractures, leading to a decrease in satisfaction and quality of life. A type of immunotherapy drug called denosumab binds to a protein called RANKL, which may help keep bone from breaking down.

NCT ID: NCT03868085 Completed - Osteopenia Clinical Trials

The Natural History of Injury-Related Disuse Osteopenia

Start date: May 31, 2017
Phase:
Study type: Observational

Determine the severity and time course (natural history) of disuse osteopenia that occurs in the lower extremity(ies) and lumbar spine of patients sustaining lower extremity injuries that require the patient to maintain restricted weight bearing status (12 weeks) following the surgical fixation of the patient's injuries. The investigators hypothesize that there will be a significant decrease in the bone mineral density in the lower limbs of patients undergoing restricted weight bearing for peri-articular injuries of the lower extremity. This loss of bone mineral density is often prolonged in its duration and may lower subsequent fracture threshold and prolong the time to recovery and return to activities.

NCT ID: NCT03761979 Completed - Osteopenia Clinical Trials

Safety and Pharmacokinetics of Orally Administered Strontium L-Lactate in Healthy Adults

Start date: March 9, 2017
Phase: N/A
Study type: Interventional

No clinical trials have evaluated strontium L-lactate (SrLac), the strontium salt of the L-enantiomer of lactic acid. Therefore, this clinical study was conducted to obtain general safety and pharmacokinetic (PK) information following acute oral intakes of three doses of SrLac by healthy adults. The data provided valuable comparisons with the pharmacokinetics of other strontium salts that are in clinical use and allowed determination of the dose of SrLac that will be useful for the management of bone health.neficial for the treatment of low bone density of osteoporosis and osteopenia.

NCT ID: NCT03688282 Completed - Osteopenia Clinical Trials

Wearable Vibration Device to Prevent Bone Loss in Postmenopausal Women--Aim 2

Start date: July 11, 2018
Phase: N/A
Study type: Interventional

The wearable vibration device aims to consistently deliver vibrations directly to the hip and spine and allowing use during many everyday activities. We propose that demonstrating higher rates of compliance and consistent delivery of optimal force, with accelerometer feedback, will provide a superior alternative to whole body vibration and is plausibly more effective at preventing bone loss in postmenopausal women than vibration platforms in the home setting.

NCT ID: NCT03480126 Completed - Osteopenia Clinical Trials

Herbal Teas on Bone Health in an Osteopenic Population

OsTea
Start date: June 1, 2018
Phase: N/A
Study type: Interventional

The project goal is to identify if herbal teas consumed three times per day over a period of three months can improve these markers of bone health as well as improve quality of life (QOL) compared to women taking placebo by increasing osteoblast activity, decreasing osteoclast activity, increasing nocturnal melatonin levels and by decreasing C-reactive protein (CRP) and cortisol levels. Our central hypothesis is that these herbal teas will improve both objective and subjective measures of bone health in a population with osteopenia not taking this regimen by reducing osteoclast activity and increasing osteoblast activity and by reducing stress and anxiety.

NCT ID: NCT03453463 Completed - Sarcopenia Clinical Trials

Exercise Effects on Sarco-Osteopenia in Older Men

Start date: January 15, 2018
Phase: N/A
Study type: Interventional

The study determined the effects of predominately resistance type exercise in combination with protein supplements on parameters of sarcopenia and osteopenia (sarco-osteopenia) in older, community dwelling men with sarcopenia and -osteopenia over 18 months.

NCT ID: NCT03294057 Completed - Osteoporosis Clinical Trials

Collaborative Care With Smart Health Management Program for Patients With Chronic Illness

Start date: October 27, 2017
Phase: N/A
Study type: Interventional

This study verifies efficacy of collaborative care with Smart Health Management Program developed for patients with chronic illness. The aim of the study is to observe the changes in clinical indicators, quality of life and health related behaviors when providing self-management programs with ICT for chronic disease patients.

NCT ID: NCT03260803 Completed - Osteopenia Clinical Trials

Oligopin Supplementation and Bone Turnover Markers and Antioxidant Changes in Postmenopausal Osteopenic Women

Start date: February 1, 2018
Phase: Phase 3
Study type: Interventional

Osteoporosis fractures impose a significant economic burden on the health system. There is evidence that osteoporosis has a high prevalence in Iran (4.8% for men and 7.7% for women), and the frequency of osteopenia is 36.8% for men and 39.3% for women in Iran Accordingly, the prevention of osteopenia progression towards osteoporosis has been considered as an important issue in medicine. Bone is a dynamic tissue that is constantly being remodeled thus the equilibrium between bone formation and resorption done by simultaneously regulating osteoclasts and osteoblasts is important. Imbalance between bone deposition and resorption contributes to reducing bone mineral density and hence increasing the risk of osteoporosis Recently, new therapies have been focused on use of medicinal herbs, especially phytochemicals. Among phytochemicals, phytonutrients, and especially polyphenols, can act both on osteoblast and on osteoclast. Pine bark extract (oligopin) is a rich source of polyphenols that exerts strong antioxidant and anti-inflammatory activities. It has also beneficial effects on bone turnover based on in vitro studies and animal models. Investigators aimed to investigate the effects of oligopin on bone turnover markers and plasma and peripheral mononuclear cells oxidative stress in postmenopausal women with osteopenia in a double-blind randomized clinical trial. Participants are forty four women with osteopenia divided into two groups randomly (22, having oligopin, 150 mg, once daily, for 12 weeks). The 2nd group (22 women with osteopenia) receives the same amount of the placebo. At the first and the end of the study, blood sample are taken to measure in order to peripheral blood mononuclear cells isolation and plasma separation. The levels of bone alkaline phosphatase and carboxy terminal collagen type I in plasma oxidative stress markers such as total anti-oxidant capacity, malondialdehyde, and protein carbonyl were evaluated. Furthermore, oxidative stress will be evaluated in peripheral blood mononuclear cells by measurement of expression and activity of magnesium superoxide dismutase,catalase and Nuclear factor (erythroid-derived 2)-like 2.

NCT ID: NCT03197623 Completed - Osteoporosis Clinical Trials

Safety and Tolerability of Intravenous LLP2A-Alendronate for Osteopenia Secondary to Glucocorticoids

Start date: October 14, 2016
Phase: Phase 1
Study type: Interventional

A Phase 1 Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose Study of the Safety and Tolerability of Intravenous LLP2A-Alendronate in Adult Men and Women with Osteopenia Secondary to Corticosteroids