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Osteoporosis clinical trials

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NCT ID: NCT02357277 Withdrawn - Osteoporosis Clinical Trials

The Effects of Inhaled Glucocorticoids on the Postmenopausal Skeleton

Start date: March 2015
Phase: Phase 4
Study type: Interventional

There are over 10 million individuals with asthma using inhaled glucocorticoids (IGCs) in the United States. While oral GCs are recognized to have destructive skeletal effects, far less is known about the effects of IGCs. This gap in our knowledge is of critical importance, not only because of the prevalence, chronic nature and long duration of IGC use, but also because several studies have found that patients using IGCs are at increased risk of fracture. Fracture risk is greatest in postmenopausal (PM) women, in whom IGCs may augment negative effects of estrogen loss and aging. The investigators hypothesize that initiation of IGCs in IGC naïve PM women will lead to decreased bone formation and uncoupling of bone turnover, a potential mechanism for the effect of IGCs on the skeleton. To test our hypothesis, the investigators will perform a randomized, controlled 4 week study of the acute effects of commonly used doses of budesonide (360 or 720 mcg) on bone turnover and circulating osteoblast precursors in 60 treatment naïve, non-asthmatic, PM women. These studies are of high clinical significance because there are currently no guidelines regarding screening, prevention or treatment for osteoporosis in patients using IGCs, nor is IGC use taken into account when calculating fracture risk in PM women, the group at highest risk of fracture. High quality evidence for low volumetric bone mineral density (BMD) and abnormal bone quality in PM women using IGCs has the potential to change clinical practice by supporting specific interventions to prevent bone loss and fractures.

NCT ID: NCT02091492 Withdrawn - Humeral Fractures Clinical Trials

Teriparatide for Fracture Repair in Humans

TERAFRAP
Start date: June 2014
Phase: Phase 3
Study type: Interventional

This study will test the hypothesis that daily subcuaneous administration of 20µg of teriparatide (TPTD) as compared to daily subcuaneous placebo for twelve weeks accelerates proximal 2-segment humerus fracture healing and improves the three dimensional structural properties of bone as measured via quantitative bone image analysis and finite element modeling assessed by quantitative computed tomography.

NCT ID: NCT01841814 Withdrawn - Lymphoma Clinical Trials

Evolution of Bone Mineral Density (BMD) in Patients With Lymphoma Undergoing Chemotherapy

LYMPHOS
Start date: April 2013
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess changes of bone mineral density (BMD) at 12 months during the therapeutic management of patients with lymphoma.

NCT ID: NCT01826656 Withdrawn - Clinical trials for Post-menopausal Osteoporosis

Bone Healing in Healthy and Post-menopausal Osteoporotic Women

Start date: May 2014
Phase: N/A
Study type: Interventional

Both the pathogenesis and the treatment of osteoporosis may potentially interfere at different levels on the multi-stage complex cascade of events involved in bone healing/regeneration. To our knowledge no human studies have been performed to clarify the potential effect of osteoporosis on post-extraction alveolar healing. The primary outcome of the study is to compare alveolar bone changes in width and height 3 months after tooth extraction in 10 post-menopausal osteoporotic women and 10 post menopausal non osteoporotic women by the use of cone-beam computer tomography (CBCT) images. The secondary outcomes considered are: clinical changes in the external contour of the ridge and periodontal parameters in the neighbouring teeth after a tooth extraction and 3 months later. In addition the accuracy of panoramic morphometric indexes in detecting osteoporosis will be measured.

NCT ID: NCT01770262 Withdrawn - Osteoporosis Clinical Trials

Development of Non-invasive Method for Quantifying Vitamin D Levels in the Body Using Spectroscopy

Start date: December 2012
Phase: N/A
Study type: Observational

Lack in vitamin D reduces the absorption of calcium in the body, accelerates bone loss and may increase the risk of fractures due to osteoporosis. An algorithm that will allow immediate and non-invasive quantification of vitamin D levels will shorten the time of diagnosis, reduce lab costs and prevent hazards or discomfort to the patient associated with a blood test. The goal of the study is therefore to develop a non-invasive method for quantifying vitamin D levels in the body using spectroscopy. 40 subjects will be recruited: 20 hospitalized patients in the rehabilitation department, diagnosed with osteoporosis and 20 healthy subjects. Spectroscopy will be used with visible light on the subject's skin and middle infrared (MIR) on the blood sample to find correlation with the chemical lab test results.

NCT ID: NCT01614171 Withdrawn - Clinical trials for Osteoporosis Pseudoglioma Syndrome

Growth Hormone for Osteoporosis Pseudoglioma Syndrome

GHOPPG
Start date: December 2013
Phase: N/A
Study type: Interventional

Osteoporosis pseudoglioma (OPPG) syndrome is a rare autosomal recessive condition of childhood osteoporosis and congenital blindness for which new treatments are needed. We have found that body fat is increased in OPPG and muscle mass is reduced. We hypothesize that growth hormone therapy will improve muscle mass and bone strength in OPPG.

NCT ID: NCT01552122 Withdrawn - Osteoporosis Clinical Trials

Efficacy and Safety of Odanacatib in Postmenopausal Women Previously Treated With Alendronate (MK-0822-050)

Start date: May 2012
Phase: Phase 3
Study type: Interventional

This study will evaluate the therapeutic effects and safety of odanacatib on bone mineral density in osteoporotic postmenopausal women who were previously treated with alendronate.

NCT ID: NCT01333267 Withdrawn - Osteoporosis Clinical Trials

One Week Comparison Study of PTH and PTHrP Infusions

Start date: January 2015
Phase: Phase 1
Study type: Interventional

This is a dose escalation study to determine the maximum tolerable dose of Parathyroid Hormone-related Protein, PTHrP, or Parathyroid Hormone, PTH, that can be given safely over one week in healthy African-American volunteers. The investigators plan to infuse low doses of intravenous PTHrP or PTH to determine if it leads to a sustained and progressive suppression of bone formation as occurs in humoral hypercalcemia of malignancy (HHM) or an increase in bone formation as occurs in hyperparathyroidism (HPT). Additionally, the investigators will assess the direct influence of PTHrP and PTH on vitamin D metabolism, markers of bone turnover, and fractional excretion of calcium. These results will be compared to previous studies of Caucasian volunteers.

NCT ID: NCT01329666 Withdrawn - Osteoporosis Clinical Trials

Primary Hyperparathyroidism (PHPT): Early Effect of Vitamin D

Start date: May 2010
Phase: Phase 2/Phase 3
Study type: Interventional

Primary hyperparathyroidism (PHPT) is a common disease that occurs in 1 in 10,000 people every year. In the presence of this condition, the parathyroid glands produce excessive amounts of parathyroid hormone (PTH), which regulates calcium levels. The high levels of parathyroid hormone remove too much calcium from bones, and then deposit the excess calcium in the blood, which is then filtered into the urine by the kidneys. Bone health is threatened by excess calcium loss which weakens bone structure. Other affected organs include the skeleton (calcium loss leads to a "weakening" of the skeleton), and the kidneys (high blood calcium can lead to kidney stones). It is now evident that the majority of patients with even mild Primary Hyperparathyroidism are vitamin D deficient. In 2009, new international guidelines for the management of asymptomatic PHPT direct physicians to measure 25-hydroxyvitamin D (D3 or 25-OHD) in all patients, and to replete the reserve of vitamin D when the level is low (< 20 ng/ml). However, no recommendations for vitamin D repletion are given, because of limited data regarding the effects of vitamin D repletion, appropriate dosing and safety. Therefore, there is an urgent need for data upon which to base such recommendations, as well as are data on the effects of such treatment upon bones. Subjects with low vitamin D3 levels will be selected for this trial. They will be given enough vitamin D3 to raise their low blood levels from a low to a normal range. The assessments in this study, including the quadruple label bone biopsy, will allow us to document the short term effects of administering vitamin D3 on changes in bone. All participants enrolled in this trial will be vitamin D3 deficient. Participants will take an antibiotic (tetracycline) 4 times a day to mark the starting point from which bone changes will be assessed. After 3 days of tetracycline, a 12 week course of vitamin D3 or placebo will be initiated. Six of 7 participants will receive the study drug (active vitamin D3), while 1 in 7 will receive a placebo (sugar pill). Ten weeks later, another 3-day course of tetracycline will be given. At the end of 12 weeks, a bone biopsy will be done. A small piece of bone (about the size of a pencil eraser) will be removed from the hip (iliac crest). The bone will be analyzed to determine the effect of vitamin D3 on primary hyperparathyroidism. There will be 4 study visits: Screening, Baseline, Week 8, and Week 12 when the bone biopsy will be performed. Study Procedures: Medical and Social History Blood tests (drawn at the study center and local Quest Lab) 24-Hour urine collection for calcium and creatinine excretion Abdominal X-ray (to assess for kidney stones) Transiliac crest Bone Biopsy

NCT ID: NCT00624481 Withdrawn - Osteoporosis Clinical Trials

Study to Evaluate Effect of Intranasal Teriparatide on Bone Mineral Density in Postmenopausal Women With Low BMD

Start date: March 2008
Phase: Phase 2
Study type: Interventional

This study is being conducted to compare the effect of increasing nasal teriparatide dosing on percent change in Bone Mineral Density (BMD) of the lumbar spine after 24 weeks of therapy in postmenopausal women with low bone mineral density.