scholarly journals Vertebroplasty for osteoporotic vertebral fracture

RMD Open ◽  
2021 ◽  
Vol 7 (2) ◽  
pp. e001655
Author(s):  
Christian Roux ◽  
Bernard Cortet ◽  
Valérie Bousson ◽  
Thierry Thomas
Keyword(s):  
Vertebral Fracture ◽  
Case Series ◽  
Bed Rest ◽  
Osteoporotic Vertebral Fracture ◽  
Open Label ◽  
Double Blind ◽  
Appropriate Care ◽  
Relieve Pain ◽  
Large Benefit ◽  
Spinal Orthoses

Appropriate care of patients with a recent painful osteoporotic vertebral fracture (VF) requires immobilisation, analgesics and spinal orthoses. Some VFs are however responsible for disabling pain and prolonged bed rest. In this context, vertebroplasty techniques have been proposed with a large benefit in case series and open-label randomised studies, but lack efficacy in three among four double-blind randomised studies. The objectives of the treatment of a recent painful VF are to relieve pain and to preserve mechanical conditions. With this in mind, we report an experts’ opinion paper on the indications for vertebroplasty and research agenda for clinical studies.

scholarly journals Effects of conservative treatment of 2-week rigorous bed rest on muscle disuse atrophy in osteoporotic vertebral fracture patients

2021 ◽  
Vol 16 (1) ◽  
pp. 8-13
Author(s):  
Akira Ikumi ◽  
Toru Funayama ◽  
Sho Terajima ◽  
Satoshi Matsuura ◽  
Akihiro Yamaji ◽  
...  
Keyword(s):  
Vertebral Fracture ◽  
Conservative Treatment ◽  
Bed Rest ◽  
Osteoporotic Vertebral Fracture ◽  
Disuse Atrophy ◽  
Muscle Disuse

scholarly journals Intra-spinal epidural leakage of bone cement during vertebroplasty of an osteoporotic vertebral fracture: case report and review of literature

2019 ◽  
Vol 5 (6) ◽  
pp. 1222
Author(s):  
Tushar N. Rathod ◽  
Kunal A. Shah ◽  
Chetan Shende
Keyword(s):  
Vertebral Fracture ◽  
Rare Complication ◽  
Posterior Instrumentation ◽  
Compression Fracture ◽  
Cement Leakage ◽  
Intractable Pain ◽  
Osteoporotic Vertebral Fracture ◽  
Adjacent Vertebral Body ◽  
Body Fracture ◽  
Relieve Pain

<p class="abstract">Vertebral fractures are one of the most common complications of osteoporosis. Prolonged and intractable pain leads to immobilization and significant morbidity. Vertebroplasty is designed primarily to relieve pain, and the procedure is considered when osteoporotic vertebral fracture does not respond to a reasonable period of conservative care. Vertebroplasty has a low complication rate with most common complication being adjacent vertebral body fracture and rare complication due to extra-vertebral cement leakage causing nerve root compression or pulmonary embolism. We report a case of 55 year old lady with osteoporotic D12 wedge compression fracture subjected to vertebroplasty resulting in intraspinal cement leakage noticed intra-operatively. Patient underwent immediate decompression, cement extraction and posterior instrumentation. Postoperative course was uneventful.</p>

Fluoxetine in the Treatment of Premenstrual Dysphoric Disorder

2002 ◽  
Vol 36 (4) ◽  
pp. 713-717
Author(s):  
Roxane R Carr ◽  
Mary HH Ensom
Keyword(s):  
English Language ◽  
Meta Analysis ◽  
Case Series ◽  
Premenstrual Dysphoric Disorder ◽  
Small Sample ◽  
Open Label ◽  
Double Blind ◽  
Late Luteal Phase ◽  
Study Selection ◽  
Small Sample Sizes

OBJECTIVE: To examine the role of fluoxetine in the treatment of premenstrual dysphoric disorder (PMDD). DATA SOURCES: Search strategy included MEDLINE (1966–February 2002), Embase (1988–February 2002), HealthStar (1975–December 2000), Current Contents (1996–November 2001), and Copernic (November 2001). Search terms included fluoxetine, premenstrual dysphoric disorder, PMDD, late luteal-phase dysphoric disorder, and severe premenstrual syndrome. STUDY SELECTION: English-language human studies were selected and evaluated based on quality of evidence. DATA SYNTHESIS: Eight prospective trials (3 double-blind, placebo-controlled, crossover; 3 double-blind, randomized, controlled; 2 open-label), 1 case series, and 1 meta-analysis were identified. Although 6 of the studies involved small sample sizes (n < 50), all found fluoxetine to be effective in the treatment of PMDD. CONCLUSIONS: Despite limited data, fluoxetine 20 mg/d appears to be effective in the treatment of PMDD. However, adverse effects, particularly headaches and sexual dysfunction, are possible. Given the long half-life of fluoxetine and the short duration of PMDD symptoms per cycle, larger, well-designed clinical trials evaluating intermittent dosing for only 1 week or a few doses need to be performed.

Long-term cariprazine treatment for the prevention of relapse in patients with schizophrenia: A randomized, double-blind, placebo-controlled trial

2020 ◽  
pp. 27-37
Author(s):  
Suresh Durgam ◽  
Willie Earley ◽  
Rui Li ◽  
Dayong Li ◽  
Kaifeng Lu ◽  
...  
Keyword(s):  
Safety Profile ◽  
Relapse Prevention ◽  
Controlled Trial ◽  
Fixed Dose ◽  
Open Label ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Randomized Controlled ◽  
Time To Relapse

Cariprazine, a dopamine D3/D2 receptor partial agonist with preference for D3 receptors, has demonstrated efficacy in randomized controlled trials in schizophrenia. This multinational, randomized, double-blind, placebo-controlled, parallel-group study evaluated the efficacy, safety, and tolerability of cariprazine for relapse prevention in adults with schizophrenia; total study duration was up to 97 weeks. Schizophrenia symptoms were treated/stabilized with cariprazine 3—9 mg/d during 20-week open-label treatment consisting of an 8-week, flexible-dose run-in phase and a 12-week fixed-dose stabilization phase. Stable patients who completed open-label treatment could be randomized to continued cariprazine (3, 6, or 9 mg/d) or placebo for double-blind treatment (up to 72 weeks). The primary efficacy parameter was time to relapse (worsening of symptom scores, psychiatric hospitalization, aggressive/violent behavior, or suicidal risk); clinical measures were implemented to ensure safety in case of impending relapse. A total of 264/765 patients completed open-label treatment; 200 eligible patients were randomized to double-blind placebo (n = 99) or cariprazine (n = 101). Time to relapse was significantly longer in cariprazine — versus placebo-treated patients (P = .0010, log-rank test). Relapse occurred in 24.8% of cariprazine- and 47.5% of placebo-treated patients (hazard ratio [95% CI] = 0.45 [0.28, 0.73]). Akathisia (19.2%), insomnia (14.4%), and headache (12.0%) were reported in ≥ 10% of patients during open-label treatment; there were no cariprazine adverse events ≥ 10% during double-blind treatment. Long-term cariprazine treatment was significantly more effective than placebo for relapse prevention in patients with schizophrenia. The long-term safety profile in this study was consistent with the safety profile observed in previous cariprazine clinical trials. ClincalTrials.gov identifier: NCT01412060. Key words: schizophrenia; cariprazine; long-term treatment; relapse prevention; randomized controlled trial; oral antipsychotics

Evaluating Thrombin Inhibition in Alzheimer’s Disease (The BEACON Trial): Protocol for a Pilot Study (Preprint)

2019 ◽  
Author(s):  
Cláudia Yang Santos ◽  
Christine Getter ◽  
John Stoukides ◽  
Brian Ott ◽  
Stephen Salloway ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Pilot Study ◽  
Cognitive Performance ◽  
Thrombin Inhibitor ◽  
Placebo Control ◽  
Open Label ◽  
Double Blind ◽  
Thrombin Inhibition ◽  
Approved Drugs

BACKGROUND The precise mechanisms whereby cardiovascular risk factors increase the risk of Alzheimer’s disease (AD) have not been delineated. We reported that microvessels isolated from AD brains overexpress a diverse array of neurotoxic and inflammatory proteins, which is consistent with the process of vascular activation. In pre-clinical studies using AD animal models we showed that a vascular activation inhibitor reduced vascular-derived neuroinflammation and improved cognitive performance. Thrombin is a key mediator of cerebrovascular activation in AD. OBJECTIVE This study aims to investigate the safety and potential efficacy of the direct thrombin inhibitor dabigatran, in patients with mild cognitive impairment (MCI) or mild AD to decrease vascular-derived neuroinflammation and improve cognitive performance. METHODS Participants will be enrolled then evaluated quarterly throughout the 24-month study. This is a 24-month randomized-control, double-blind, placebo-controlled, multicenter, delayed-start, pilot study evaluating thrombin inhibition in people with biomarker-confirmed MCI probably due to AD or mild AD. 40 - 60 participants will be recruited between 50 - 85 years old. In the initial 9-months of study, either dabigatran or placebo will be orally administered to patients at a dose of 150 mg per day. After 9 months of the placebo-control (Phase I), the placebo arm will cross-over to an active, open-label (Phase II) where all patients will be treated with a 150 mg daily dose of dabigatran orally for an additional 12 months. A 3-month non-treatment follow-up period will assess duration of effects. RESULTS Beginning in July 2019, and concluding in August 2022, this study is expected to publish final results in January 2023. CONCLUSIONS BEACON is a first-in-kind randomized clinical trial targeting thrombin activation in AD therapeutics. This trial will stimulate translational investigations of an FDA-approved drugs in a newly defined therapeutic areas. CLINICALTRIAL Clinicaltrials.gov NCT03752294

scholarly journals Tasimelteon safely and effectively improves sleep in Smith–Magenis syndrome: a double-blind randomized trial followed by an open-label extension

2021 ◽  
Author(s):  
Christos M. Polymeropoulos ◽  
Justin Brooks ◽  
Emily L. Czeisler ◽  
Michaela A. Fisher ◽  
Mary M. Gibson ◽  
...  
Keyword(s):  
Sleep Quality ◽  
Crossover Study ◽  
Total Sleep Time ◽  
Sleep Time ◽  
Open Label ◽  
Double Blind ◽  
Open Label Study ◽  
Label Study ◽  
Sleep Complaints ◽  
Open Label Extension

Abstract Purpose To assess the efficacy of tasimelteon to improve sleep in Smith–Magenis syndrome (SMS). Methods A 9-week, double-blind, randomized, two-period crossover study was conducted at four US clinical centers. Genetically confirmed patients with SMS, aged 3 to 39, with sleep complaints participated in the study. Patients were assigned to treatment with tasimelteon or placebo in a 4-week crossover study with a 1-week washout between treatments. Eligible patients participated in an open-label study and were followed for >3 months. Results Improvement of sleep quality (DDSQ50) and total sleep time (DDTST50) on the worst 50% of nights were primary endpoints. Secondary measures included actigraphy and behavioral parameters. Over three years, 52 patients were screened, and 25 patients completed the randomized portion of the study. DDSQ50 significantly improved over placebo (0.4, p = 0.0139), and DDTST50 also improved (18.5 minutes, p = 0.0556). Average sleep quality (0.3, p = 0.0155) and actigraphy-based total sleep time (21.1 minutes, p = 0.0134) improved significantly, consistent with the primary outcomes. Patients treated for ≥90 days in the open-label study showed persistent efficacy. Adverse events were similar between placebo and tasimelteon. Conclusion Tasimelteon safely and effectively improved sleep in SMS.

Sign in / Sign up

Export Citation Format

Share Document