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  1. Article ; Online: LETTERS TO THE EDITOR.

    McClung, Michael R

    Menopause (New York, N.Y.)

    2022  Volume 29, Issue 4, Page(s) 497–498

    Language English
    Publishing date 2022-03-25
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1205262-0
    ISSN 1530-0374 ; 1072-3714
    ISSN (online) 1530-0374
    ISSN 1072-3714
    DOI 10.1097/GME.0000000000001969
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Should vitamin D supplements be prescribed routinely for midlife women?: Released July 13, 2022.

    McClung, Michael R

    Menopause (New York, N.Y.)

    2022  Volume 29, Issue 11, Page(s) 1329–1330

    MeSH term(s) Female ; Humans ; Dietary Supplements ; Vitamin D Deficiency/epidemiology ; Vitamin D
    Chemical Substances Vitamin D (1406-16-2)
    Language English
    Publishing date 2022-10-16
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1205262-0
    ISSN 1530-0374 ; 1072-3714
    ISSN (online) 1530-0374
    ISSN 1072-3714
    DOI 10.1097/GME.0000000000002066
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Role of bone-forming agents in the management of osteoporosis.

    McClung, Michael R

    Aging clinical and experimental research

    2021  Volume 33, Issue 4, Page(s) 775–791

    Abstract: Recent evidence confirms the superiority of osteoanabolic therapy compared to anti-remodeling drugs for rapid improvement in bone density and fracture risk reduction, providing strong justification for the use of these anabolic agents as the initial ... ...

    Abstract Recent evidence confirms the superiority of osteoanabolic therapy compared to anti-remodeling drugs for rapid improvement in bone density and fracture risk reduction, providing strong justification for the use of these anabolic agents as the initial therapy in high-risk patients, to be followed by anti-remodeling therapy. This review will highlight the results of recent studies and define the current status of osteoanabolic therapy for osteoporosis.
    MeSH term(s) Bone Density ; Bone Density Conservation Agents/therapeutic use ; Humans ; Osteoporosis/drug therapy ; Parathyroid Hormone-Related Protein ; Teriparatide
    Chemical Substances Bone Density Conservation Agents ; Parathyroid Hormone-Related Protein ; Teriparatide (10T9CSU89I)
    Language English
    Publishing date 2021-02-16
    Publishing country Germany
    Document type Journal Article ; Review
    ZDB-ID 2104785-6
    ISSN 1720-8319 ; 1594-0667
    ISSN (online) 1720-8319
    ISSN 1594-0667
    DOI 10.1007/s40520-020-01708-8
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Development and cross-validation of a circumference-based predictive equation to estimate body fat in an active population.

    Taylor, Kathryn M / Castellani, Michael P / Bartlett, P Matthew / Oliver, Tyler E / McClung, Holly L

    Obesity science & practice

    2024  Volume 10, Issue 2, Page(s) e747

    Abstract: Objective: The U.S. Army uses sex-specific circumference-based prediction equations to estimate percent body fat (%BF) to evaluate adherence to body composition standards. The equations are periodically evaluated to ensure that they continue to ... ...

    Abstract Objective: The U.S. Army uses sex-specific circumference-based prediction equations to estimate percent body fat (%BF) to evaluate adherence to body composition standards. The equations are periodically evaluated to ensure that they continue to accurately assess %BF in a diverse population. The objective of this study was to develop and validate alternative field expedient equations that may improve upon the current Army Regulation (AR) body fat (%BF) equations.
    Methods: Body size and composition were evaluated in a representatively sampled cohort of 1904 active-duty Soldiers (1261 Males, 643 Females), using dual-energy X-ray absorptiometry (%BF
    Results: Three new equations were developed using one to three circumference sites. The predictive values of waist, abdomen, hip circumference, weight and height were evaluated. Changing from a 3-site model to a 1-site model had minimal impact on measurements of model accuracy and performance. Male-specific equations demonstrated larger gains in accuracy, whereas female-specific equations resulted in minor improvements in accuracy compared to existing AR equations. Equations performed similarly in the second external validation cohort.
    Conclusions: The equations developed improved upon the current AR equation while demonstrating robust and consistent results within an external population. The 1-site waist circumference-based equation utilized the abdominal measurement, which aligns with associated obesity related health outcomes. This could be used to identify individuals at risk for negative health outcomes for earlier intervention.
    Language English
    Publishing date 2024-04-18
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2836381-4
    ISSN 2055-2238 ; 2055-2238
    ISSN (online) 2055-2238
    ISSN 2055-2238
    DOI 10.1002/osp4.747
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Romosozumab for the treatment of osteoporosis.

    McClung, Michael R

    Osteoporosis and sarcopenia

    2018  Volume 4, Issue 1, Page(s) 11–15

    Abstract: Romosozumab, a specific inhibitor of sclerostin, is a unique approach to therapy for postmenopausal osteoporosis and related disorders. The elucidation of sclerostin deficiency as the molecular defect of syndromes of high bone mass with normal quality, ... ...

    Abstract Romosozumab, a specific inhibitor of sclerostin, is a unique approach to therapy for postmenopausal osteoporosis and related disorders. The elucidation of sclerostin deficiency as the molecular defect of syndromes of high bone mass with normal quality, and the pivotal role of sclerostin as a mediator of osteoblastic activity and bone formation, provided the platform for the evaluation of inhibitors of sclerostin to activate bone formation. An extensive preclinical program and 2 large fracture endpoint trials with romosozumab, a sclerostin-binding antibody, have been completed. This review will highlight the results of those studies and describe the current status of romosozumab as a potential therapy for osteoporosis.
    Language English
    Publishing date 2018-03-27
    Publishing country Netherlands
    Document type Journal Article ; Review
    ISSN 2405-5263
    ISSN (online) 2405-5263
    DOI 10.1016/j.afos.2018.03.002
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: Drug holidays in women treated for postmenopausal osteoporosis.

    McClung, Michael R

    Menopause (New York, N.Y.)

    2018  Volume 25, Issue 10, Page(s) 1152–1154

    Abstract: In this Practice Pearl, the experience with long-term treatment of osteoporosis with bisphosphonates and denosumab will be reviewed as well as the effects of discontinuing therapy, providing the platform for recommendations about "drug holidays" for ... ...

    Abstract In this Practice Pearl, the experience with long-term treatment of osteoporosis with bisphosphonates and denosumab will be reviewed as well as the effects of discontinuing therapy, providing the platform for recommendations about "drug holidays" for these medications.
    MeSH term(s) Bone Density/drug effects ; Bone Density Conservation Agents/adverse effects ; Bone Density Conservation Agents/therapeutic use ; Denosumab/adverse effects ; Denosumab/therapeutic use ; Diphosphonates/adverse effects ; Diphosphonates/therapeutic use ; Female ; Femoral Fractures/epidemiology ; Humans ; Osteoporosis, Postmenopausal/drug therapy ; Risk ; Spinal Fractures/prevention & control ; Time Factors
    Chemical Substances Bone Density Conservation Agents ; Diphosphonates ; Denosumab (4EQZ6YO2HI)
    Language English
    Publishing date 2018-07-25
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1205262-0
    ISSN 1530-0374 ; 1072-3714
    ISSN (online) 1530-0374
    ISSN 1072-3714
    DOI 10.1097/GME.0000000000001141
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: Denosumab for the treatment of osteoporosis.

    McClung, Michael R

    Osteoporosis and sarcopenia

    2017  Volume 3, Issue 1, Page(s) 8–17

    Abstract: Denosumab, a specific inhibitor of RANK ligand, is a novel therapy for postmenopausal osteoporosis and related disorders. An extensive clinical development program has evaluated the clinical efficacy and safety of denosumab with several thousand patients ...

    Abstract Denosumab, a specific inhibitor of RANK ligand, is a novel therapy for postmenopausal osteoporosis and related disorders. An extensive clinical development program has evaluated the clinical efficacy and safety of denosumab with several thousand patients being followed for up to 10 years. Combined with more than six years of postmarketing experience, these studies provide substantial confidence that denosumab is a convenient and appropriate treatment for patients, including Asians, at high risk for fracture. This review will summarize the clinical development of denosumab and lessons learned since its approval for clinical use in 2010.
    Language English
    Publishing date 2017-02-15
    Publishing country Netherlands
    Document type Journal Article ; Review
    ISSN 2405-5263
    ISSN (online) 2405-5263
    DOI 10.1016/j.afos.2017.01.002
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article ; Online: Long-term effect of denosumab on bone microarchitecture as assessed by tissue thickness-adjusted trabecular bone score in postmenopausal women with osteoporosis: results from FREEDOM and its open-label extension.

    Hans, Didier / McDermott, Michele / Huang, Shuang / Kim, Min / Shevroja, Enisa / McClung, Michael

    Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA

    2023  Volume 34, Issue 6, Page(s) 1075–1084

    Abstract: In postmenopausal women with osteoporosis, up to 10 years of denosumab treatment significantly and continuously improved bone microarchitecture assessed by tissue thickness-adjusted trabecular bone score, independently of bone mineral density. Long-term ... ...

    Abstract In postmenopausal women with osteoporosis, up to 10 years of denosumab treatment significantly and continuously improved bone microarchitecture assessed by tissue thickness-adjusted trabecular bone score, independently of bone mineral density. Long-term denosumab treatment decreased the number of high fracture-risk patients and shifted more patients to lower fracture-risk categories.
    Purpose: To investigate the long-term effect of denosumab on bone microarchitecture assessed by tissue thickness-adjusted trabecular bone score (TBS
    Methods: Postmenopausal women with lumbar spine (LS) or total hip BMD T-score <-2.5 and ≥-4.0 who completed the FREEDOM DXA substudy and continued in OLE were included. Patients received either denosumab 60 mg subcutaneously every 6 months for 3 years and same-dose open-label denosumab for 7 years (long-term denosumab; n=150) or placebo for 3 years and open-label denosumab for 7 years (crossover denosumab; n=129). BMD and TBS
    Results: In long-term denosumab group, continued increases from baseline to years 4, 5, 6, 8, and 10 in BMD (11.6%, 13.7%, 15.5%, 18.5%, and 22.4%) and TBS
    Conclusion: In postmenopausal women with osteoporosis, up to 10 years of denosumab significantly and continuously improved bone microarchitecture assessed by TBS
    MeSH term(s) Female ; Humans ; Bone Density ; Bone Density Conservation Agents/pharmacology ; Bone Density Conservation Agents/therapeutic use ; Cancellous Bone ; Denosumab/pharmacology ; Denosumab/therapeutic use ; Fractures, Bone/chemically induced ; Lumbar Vertebrae ; Osteoporosis/drug therapy ; Osteoporosis, Postmenopausal/drug therapy ; Osteoporosis, Postmenopausal/chemically induced ; Postmenopause
    Chemical Substances Bone Density Conservation Agents ; Denosumab (4EQZ6YO2HI)
    Language English
    Publishing date 2023-03-02
    Publishing country England
    Document type Clinical Trial ; Journal Article
    ZDB-ID 1064892-6
    ISSN 1433-2965 ; 0937-941X
    ISSN (online) 1433-2965
    ISSN 0937-941X
    DOI 10.1007/s00198-023-06708-8
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article: Romosozumab Efficacy in Postmenopausal Women With No Prior Fracture Who Fulfill Criteria for Very High Fracture Risk.

    McClung, Michael R / Betah, Donald / Deignan, Cynthia / Shi, Yifei / Timoshanko, Jen / Cosman, Felicia

    Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists

    2023  Volume 29, Issue 9, Page(s) 716–722

    Abstract: Objective: We evaluated the efficacy of romosozumab in women from FRAME who had no prior fracture but met other criteria for very high fracture risk (VHFR).: Methods: In FRAME, postmenopausal women received romosozumab or placebo for 12 months (year ... ...

    Abstract Objective: We evaluated the efficacy of romosozumab in women from FRAME who had no prior fracture but met other criteria for very high fracture risk (VHFR).
    Methods: In FRAME, postmenopausal women received romosozumab or placebo for 12 months (year 1) followed by denosumab for 12 months (year 2). In this post hoc analysis, we applied the following criteria from the American Association of Clinical Endocrinology to define VHFR: lumbar spine or total hip T-score <-3.0 and/or Fracture Risk Assessment Tool probability of major osteoporotic fracture >30% or hip fracture >4.5% to women with no fracture history at baseline (no fracture-VHFR [NF-VHFR]). Incidence of new vertebral, clinical, and nonvertebral fractures and mean bone mineral density (BMD) percentage change from baseline were assessed at years 1 and 2.
    Results: Of the 7180 women in FRAME, 2825 were included in the NF-VHFR subgroup analysis. At year 1, romosozumab versus placebo reduced the incidence of new vertebral fracture (relative risk reduction [RRR]: 76%), clinical fracture (RRR: 60%), and nonvertebral fracture (RRR: 54%) (all P <.05). This fracture reduction was maintained through year 2 in women receiving the romosozumab-to-denosumab sequence versus the placebo-to-denosumab sequence for new vertebral, clinical, and nonvertebral fractures (RRR: 77%, 54%, and 46%, respectively; all P <.05). The mean BMD changes in both treatment groups were similar to those in the overall FRAME population at years 1 and 2.
    Conclusion: Romosozumab significantly reduced vertebral, clinical, and nonvertebral fracture risk and increased the BMD more than placebo in women at VHFR.
    MeSH term(s) Female ; Humans ; Antibodies, Monoclonal/therapeutic use ; Bone Density ; Bone Density Conservation Agents/therapeutic use ; Denosumab/therapeutic use ; Osteoporosis, Postmenopausal/drug therapy ; Osteoporotic Fractures/prevention & control ; Osteoporotic Fractures/etiology ; Postmenopause
    Chemical Substances Antibodies, Monoclonal ; Bone Density Conservation Agents ; Denosumab (4EQZ6YO2HI) ; romosozumab (3VHF2ZD92J)
    Language English
    Publishing date 2023-07-04
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1473503-9
    ISSN 1530-891X
    ISSN 1530-891X
    DOI 10.1016/j.eprac.2023.06.011
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: Clinical utility of anti-sclerostin antibodies.

    McClung, Michael R

    Bone

    2017  Volume 96, Page(s) 3–7

    Abstract: Based on a platform of strong preclinical data, several studies in humans have demonstrated that inhibiting sclerostin with specific antibodies results in a brisk albeit transient anabolic response in the skeleton without an accompanying increase in bone ...

    Abstract Based on a platform of strong preclinical data, several studies in humans have demonstrated that inhibiting sclerostin with specific antibodies results in a brisk albeit transient anabolic response in the skeleton without an accompanying increase in bone resorption. Impressive increases in bone mineral density and bone strength have been demonstrated. Other than mild injection site reactions, therapy for up to 2years has been well tolerated. The restriction of sclerostin expression almost exclusively to skeletal tissues, coupled with the absence of recognized medical problems in patients with heterozygous sclerostin deficiency, provides promise that the drug can be used safely. Recent results from a Phase 3 fracture trial suggest that anti-sclerostin therapy will be a useful and welcomed new treatment for patients with severe osteoporosis in need of skeletal reconstruction.
    Language English
    Publishing date 2017-03
    Publishing country United States
    Document type Journal Article
    ZDB-ID 632515-4
    ISSN 1873-2763 ; 8756-3282
    ISSN (online) 1873-2763
    ISSN 8756-3282
    DOI 10.1016/j.bone.2016.12.012
    Database MEDical Literature Analysis and Retrieval System OnLINE

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